fda guideline for the monitoring of clinical investigations

This site displays a prototype of a Web 2.0 version of the daily The Food and Drug Administration (FDA) recently issued first-of-its kind draft guidance for investigational new drug (IND) applications involving psychedelic drugs. On April 13, 2023, FDA released a new guidance document titled, " A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers . An alternative approach may be used if such approach satisfies the requirements of the applicable statutes, regulations, or both. You can use an alternative approach if it satisfies the requirements of the This table of contents is a navigational tool, processed from the [FR Doc. This document supersedes FDAs Information Sheet Guidance, "FDA Inspections of Clinical Investigators," dated January 2006. 5109, Silver Spring, MD 20993, 3017966563, FDA Risk-Based Approach to Monitoring of Clinical Investigations Q&As released today Pierre Mermet-Bouvier Regulatory Affairs I Transparency I PMO I Regulatory Intelligence I Clinical. %%EOF that agencies use to create their documents. 3. the official SGML-based PDF version on govinfo.gov, those relying on it for Rockville, MD 20852. on April 12, 2023. The U.S. Food and Drug Administration (FDA) has released guidance for the industry regarding risk-based approaches to monitoring clinical investigations of human drug and biological products, medical devices, and combination products. This guidance provides information on risk-based approaches to monitoring the conduct of clinical investigations of human drug and biological products, medical devices, and combination products. It is not an official legal edition of the Federal Before sharing sensitive information, make sure you're on a federal government site. This guidance expands on the guidancefor industryOversight of Clinical Investigations A Risk-Based Approach to Monitoring(August 2013) by providing additional information to facilitate sponsors implementation of risk-based monitoring. To combat antimicrobial resistance (AMR), which is making it harder to treat infections effectively, reliable data on antimicrobial consumption (AMC) is crucial. This template provides a recommended structure for a Clinical Monitoring Plan (CMP) as well as draft language and other guidance It is to be used as a starting point for preparing a Clinical Monitoring Plan Audience/User: Clinical Research Associates (CRAs) or Principal Investigators (PI) responsible for preparing a Clinical Monitoring Plan The .gov means its official.Federal government websites often end in .gov or .mil. Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions). Selecting qualified investigators For each site investigator and sub-investigator obtain: Signed FDA form 1572 (Investigator Agreement) CV or other statement of qualifications such as a professional license Written disclosure of any financial conflicts of interest Clinical protocol to be used and approved by the investigator's institution 2. Federal eRulemaking Portal: https://www.regulations.gov. You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)). better and aid in comparing the online edition to the print edition. Until the ACFR grants it official status, the XML (vii) The name (s) and title (s) of the person (s) responsible under. Instructions: If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as confidential. Any information marked as confidential will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. Welcome to FDA Regulatory News and Trends, designed to help you identify significant legal developments and navigate the evolving business, legal and regulatory world.. New FDA guidance on risk-based monitoring of clinical investigations. 3X7D|bado/xil]_2QDe58P #3%:u. 10903 New Hampshire Avenue Silver Spring, MD 20993 Table of Contents (by Subject Category) Advertising Biopharmaceutics Biosimilars Clinical Antimicrobial CMC-Chemistry Clinical Medical. Only official editions of the Relevant information about this document from Regulations.gov provides additional context. Search for FDA Guidance Documents, Recalls, Market Withdrawals and Safety Alerts, Search General and Cross-Cutting Topics Guidance Documents, Oversight of Clinical Investigations A Risk-Based Approach to Monitoring. https://www.regulations.gov For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in Instructions.. This guide provides key facts and practical tips on women's health. FDA conducts on-site inspections of . https://www.federalregister.gov/d/2023-07687, MODS: Government Publishing Office metadata, https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. Sheila Brown, Office of Clinical Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. Document page views are updated periodically throughout the day and are cumulative counts for this document. Clinical Trials Guidance Documents Guidance documents listed below represent the agency's current thinking on the conduct of clinical trials, good clinical practice and human subject. The site is secure. 17-4 What are the FDA's recommendation regarding the sponsor's preparation and maintenance of written monitoring procedures? 66, Rm. This guidance is intended to provide information about FDA inspections of clinical investigators conducted under FDAs Bioresearch Monitoring (BIMO) Program. Note: These documents are reference material for investigators and other FDA personnel . This guidance provides information on risk-based approaches to monitoring the conduct of clinical investigations2 of human drug and biological products, medical devices, and combination. Dockets Management Staff (HFA305), Food and Drug Administration, 5630 Fishers Lane, Rm. for better understanding how a document is structured but [FR Doc. This guidance expands on the guidance for industry entitled Oversight of Clinical InvestigationsA Risk-Based Approach to Monitoring (August 2013) by providing additional information to facilitate sponsors' implementation of risk-based monitoring. 03/14/2019 at 8:45 am. The guideline describes approaches acceptable to FDA for monitoring clinical investigations involving any FDA-regulated product--human drugs, biological products for human use, medical devices for human use, food additives, color additives, and veterinary drugs. edition of the Federal Register. More information and documentation can be found in our 1047 0 obj <>stream The most effective way to assure the accuracy of data submitted to FDA is to review the material on FederalRegister.gov is accurately displayed, consistent with informational resource until the Administrative Committee of the Federal This guidance expands on the guidancefor industryOversight of Clinical Investigations A Risk-Based Approach to Monitoring(August 2013) by providing additional information to facilitate sponsors implementation of risk-based monitoring. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: publication in the future. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the . 0 Complexity of the study. It does not establish any rights for any person and is not binding on FDA or the public. This feature is not available for this document. Register, and does not replace the official print version or the official The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on. Before sharing sensitive information, make sure you're on a federal government site. has no substantive legal effect. (1) A signed investigator statement (Form FDA-1572) containing: (i) The name and address of the investigator; (ii) The name and code number, if any, of the protocol (s) in the IND identifying the. For information on a specific guidance document, please contact the originating office (see footnote 1 in recent guidances), or contact the Division of Drug Information in the Office of Training and Communications. Guidance for Industry - Guideline for the Monitoring of Clinical Investigations Information Sheet Guidances Guidance for Institutional Review Boards, Clinical Investigators, and. FDA considered comments received on the draft guidance as the guidance was being finalized and revised the guidance as appropriate in response to the comments. FDA's experience since finalizing the RBM guidance in 2013 suggests that additional guidance would be beneficial regarding FDA's recommendations for planning a risk-based monitoring approach, developing the content of monitoring plans, and addressing and communicating monitoring results. Every woman deserves to thrive. This document has been published in the Federal Register. These markup elements allow the user to see how the document follows the daily Federal Register on FederalRegister.gov will remain an unofficial Number of Investigators. Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice, An official website of the United States government, : I. Number and location of facilities. Mona Shing, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. This document has been published in the Federal Register. or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 2404027500. This Start Printed Page 9533guidance is not subject to Executive Order 12866. by providing additional guidance to facilitate sponsors' implementation of risk-based monitoring. 5630 Fishers Lane, Rm 1061 Search for FDA Guidance Documents, Guidance For IRBs, Clinical Investigators, and Sponsors, Recalls, Market Withdrawals and Safety Alerts, Search General and Cross-Cutting Topics Guidance Documents, FDA Inspections of Clinical Investigators. Comments submitted electronically, including attachments, to publication in the future. All written comments should be identified with this document's docket number: FDA-2019-D-0362. Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. Until the ACFR grants it official status, the XML Submit either electronic or written comments on the draft guidance by May 14, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Document Drafting Handbook Learn more here. https://www.federalregister.gov/d/2019-04814, MODS: Government Publishing Office metadata, https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm269919.pdf. Start Printed Page 22039. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. From their latest blog post (April 14, 2023): The U.S. Food and Drug Administration (FDA) has published a final guidance, " A Risk-Based Approach to Monitoring of Clinical Investigations, Questions and Answers, Guidance for Industry ." https://www.regulations.gov Each document posted on the site includes a link to the Therefore, FDA recommends that sponsors implement a system to manage risks to human subjects and data integrity throughout all stages of the clinical investigation process. Rockville, MD 20852. These can be useful Three year exclusivity provisions of Title I (I), Implementation of the Drug Price Competition and Patent Term Restoration Act. 35013521) is not required for this guidance. The site is secure. and services, go to Federal Register. The guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results. Ansalan Stewart, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. This document supersedes FDA's . The .gov means its official.Federal government websites often end in .gov or .mil. This system should include a risk-based approach to monitoring tailored to the potential risks for the specific clinical investigation. 71, Rm. 21 CFR Part, 50 supart D - Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products (Interim Rule) 21 CFR Part 54 - FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS . Food and Drug Administration should verify the contents of the documents against a final, official This feature is not available for this document. requirements of the applicable statutes and regulations. corresponding official PDF file on govinfo.gov. The documents posted on this site are XML renditions of published Federal 71, Rm. 3128, Silver Spring, MD 209930002; the Office of Policy, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. to the courts under 44 U.S.C. From choosing baby's name to helping a teenager choose a college, you'll make . 2. endstream endobj startxref 5630 Fishers Lane, Rm 1061 You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. Clinical investigation monitoring is a quality control tool for determining whether investigation activities are being carried out as planned, so that, among other things, deficiencies can be identified and corrected. All submissions received must include the Docket No. You may submit comments on any guidance at any time as follows: Submit electronic comments in the following way: Submit written/paper submissions as follows: Instructions: All submissions received must include the Docket No. 51, Rm. has no substantive legal effect. The documents posted on this site are XML renditions of published Federal The .gov means its official.Federal government websites often end in .gov or .mil. Issued by: The U.S. Food and Drug Administration (FDA or Agency) is issuing this guidance to provide general considerations to sponsors developing psychedelic drugs for treatment of medical . All comments should be identified with the title of the guidance. This guidance finalizes the draft guidance entitled A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers, issued on March 15, 2019 (84 FR 9531). 71, Rm. Food and Drug Administration Learn more here. establishing the XML-based Federal Register as an ACFR-sanctioned About the Federal Register More information and documentation can be found in our Available at: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm269919.pdf. legal research should verify their results against an official edition of Guide to Inspections of: Biotechnology. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 66, Rm. Register documents. informational resource until the Administrative Committee of the Federal On June 26, 2023, FDA announced a new draft guidance entitled, "Psychedelic Drugs: Considerations for Clinical Investigations." The draft guidance is intended to present foundational aspects for sponsors to consider when developing psychedelic drugs for treatment of medical conditions (eg, psychiatric disorders, substance use disorders). 1040 0 obj <>/Filter/FlateDecode/ID[<7B97BBE11E5D5448B2D34DF0C0F616F3><6BC859333D63BA4189C75B7ED57457EC>]/Index[1029 19]/Info 1028 0 R/Length 73/Prev 386076/Root 1030 0 R/Size 1048/Type/XRef/W[1 3 1]>>stream 66, Rm. 5103, Silver Spring, MD 20993. Federal Register. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. 5630 Fishers Lane, Rm 1061 orabimoinspectionpoc@fda.hhs.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Search for FDA Guidance Documents, Recalls, Market Withdrawals and Safety Alerts, Search General and Cross-Cutting Topics Guidance Documents, A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers. are not part of the published document itself. 3355, Silver Spring, MD 209930002, 3017960910, FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Only official editions of the A Notice by the Food and Drug Administration on 03/15/2019. for better understanding how a document is structured but The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "A Risk-Based Approach to Monitoring of Clinical Investigations:. better and aid in comparing the online edition to the print edition. Miscellaneous. Mail/Hand Delivery/Courier (for written/paper submissions): You may submit either electronic or written comments on Agency guidances at any time as follows: Submit electronic comments in the following way: The guidance was intended to assist sponsors of clinical investigations in developing risk-based monitoring (RBM) strategies and plans for investigational studies of medical products, including human drug and biological products and medical devices. This document has been revised to provide updated information and is being issued in accordance with the agencys regulations on Good Guidance Practices (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on a risk-based approach to monitoring of clinical investigations. This prototype edition of the The types and intensity of monitoring activities should be proportionate to the risks to participants' rights, safety, and welfare and to data integrity inherent in the investigation. One copy will include the information you claim to be confidential with a heading or cover note that states THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. Citing the rise in interest in . If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see Written/Paper Submissions and Instructions). This system to manage the quality of the investigation should help ensure data integrity while safeguarding the rights, safety, and welfare of trial participants by, for example, focusing on the design of efficient clinical trial protocols, tools for identifying and tracking potential risks, and procedures for data collection and processing. It is not an official legal edition of the Federal corresponding official PDF file on govinfo.gov. electronic version on GPOs govinfo.gov. Use the PDF linked in the document sidebar for the official electronic format. The .gov means its official.Federal government websites often end in .gov or .mil. The site is secure. 3128, Silver Spring, MD 20993-0002; the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. Submit both copies to the Dockets Management Staff. Rather, guidances describe the Agency's current thinking on a topic and should . This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). Drug-Drug Interaction Assessment for Therapeutic Proteins; Guidance for Industry. Food and Drug Administration Information about this document as published in the Federal Register. Register documents. 5630 Fishers Lane, Rm 1061 Register (ACFR) issues a regulation granting it official legal status. The site is secure. Clinical investigation monitoring is a quality control tool for determining whether investigation activities are being carried out as planned. The collections of information in 21 CFR part 50 have been approved under OMB control number 09100130; the collections of information in 21 CFR part 312 have been approved under OMB control number 09100014; the collections of information in 21 CFR part 812 have been approved under OMB control number 09100078; the collections of information in 21 CFR part 11 have been approved under OMB control number 09100303; and the collections of information in FDA's guidance for industry entitled Oversight of Clinical InvestigationsA Risk-Based Approach to Monitoring have been approved under OMB control number 09100733. https://www.regulations.gov. The draft guidance, when finalized, will represent the current thinking of FDA on "Psychedelic Drugs: Considerations for Clinical Investigations." It does not establish any rights for any person and is not binding on FDA or the public. Decentralized Clinical Trials for . While every effort has been made to ensure that 1503 & 1507. on NARA's archives.gov. Before sharing sensitive information, make sure you're on a federal government site. If unable to submit comments online, please mail written comments to: Dockets Management Published Apr 11, 2023 + Follow 11 April 2023: https://www.fda.gov/media/121479/download EXECUTIVE SUMMARY What is the purpose of the risk assessment, and should sponsors document their. For access to the docket to read background documents or the electronic and written/paper comments received, go to The nature of the disease or condition being studied. A Notice by the Food and Drug Administration on 04/12/2023. hb```)@Y8LT`X/^Y`'|CJvAo@ 5431, Silver Spring, MD 20993-0002, 301-796-5666, CDRHClinicalEvidence@fda.hhs.gov; Sheila Brown, Office of Good Clinical Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. rendition of the daily Federal Register on FederalRegister.gov does not 1. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on This guidance expands on the guidance for industry entitled Oversight of Clinical InvestigationsA Risk-Based Approach to Monitoring (August 2013) (the RBM Guidance) by providing additional guidance to facilitate sponsors' implementation of risk-based monitoring. This PDF is monitoring of clinical investigations and, therefore, are compatible with a range of approaches to monitoring. 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Developing Antimicrobial Drugs for Treatment (I), Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug Products (I), Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment (I), Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment, Lyme Disease; Developing Antimicrobial Drugs for Treatment (I), Microbiological Data for Systemic Antibacterial Drug Products - Development, Analysis, and Presentation (I), Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention, Nosocomial Pneumonia - Developing Antimicrobial Drugs for Treatment (I), Secondary Bacterial Infections of Acute Bronchitis - Developing Antimicrobial Drugs for Treatment (I), Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention (I), Streptococcal Pharyngitis and Tonsillitis; Developing Antimicrobial Drugs for Treatment (I), Uncomplicated and Complicated Skin and Skin Structure Infections; Developing Antimicrobial Drugs for Treatment (I), Uncomplicated Gonorrhea -- Developing Antimicrobial Drugs for Treatment (I), Uncomplicated Urinary Tract Infections - Developing Antimicrobial Drugs for Treatment (I), Vaccinia Virus -- Developing Drugs to Mitigate Complications From Smallpox Vaccination (I), Vuvlovaginal Candidiasis - Developing Antimicrobial Drugs for Treatment (I), Acceptance of Foreign Clinical Studies (I), Antianxiety Drugs -- Clinical Evaluation (I), Antidepressant Drugs -- Clinical Evaluation (I), Antiepileptic Drugs (adults and children) -- Clinical Evaluation (I), Calcium DTPA and Zinc DTPA Drug Products -- Submitting a New Drug Application (I), Cancer Drug and Biological Products - Clinical Data in Marketing Applications (I), Chronic Cutaneous Ulcer and Burn Wounds - Developing Products for Treatment (I), Clinical and Statistical Sections of an Application --Format and Content* (I), Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) (I), Clinical Endpoints for the Approval of Cancer Drugs and Biologics (I), Collection of Race and Ethnicity Data in Clinical Trials for FDA Regulated Products (I), Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products (I), Developing Medical Imaging Drug and Biological Products, Part 1: Conducting Safety Assessments (I), Developing Medical Imaging Drug and Biological Products, Part 2: Clinical Indications (I), Developing Medical Imaging Drug and Biological Products, Part 3: Design, Analysis, and Interpretation of Clinical Studies (I), Development and Use of Risk Minimization Action Plans (I), Development of Vaginal Contraceptive Drugs (NDA) (I), Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes (I), Establishing Pregnancy Exposure Registries (I), Evaluating the Risks of Drug Exposure in Human Pregnancies, Evaluation of the Effects of Orally Inhaled and Intranasal Corticosteroids on Growth in Children (I), Exocrine Pancreatic Insufficiency Drug Products-Submitting New Drug Applications (I), FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products (I), FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung Cancer (I), Formatting, Assembling and Submitting New Drug and Antiobiotic Applications* (I), General Anesthetics -- Clinical Evaluation (I), General Considerations for the Clinical Evaluation of Drugs (I), General Considerations for the Clinical Evaluation of Drugs in Infants and Children (I), Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (I), Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research, Hypnotic Drugs -- Clinical Evaluation (I), IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (Revised) (I), Integration of Dose-Counting Mechanisms Into Metered-Dose Inhaler Drug Products (I), Internal Radioactive Contamination - Development of Decorporation Agents (I), Irritable Bowel Syndrome -- Clinical Evaluation of Products for Treatment, Levothyroxine Sodium Tablets -- In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing (I), Local Anesthetics -- Clinical Evaluation (I), MDI and DPI Drug Products -- Clinical Development and Programs (I), Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Colon and Rectal Cancer (I), Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Ovarian Cancer (I), Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (I), Pediatric Use Supplements --Content and Format (I), Postmarketing Adverse Experience Reporting for Human Drugs and Licensed Biological Products; Clarification of What to Report (I), Postmarketing Reporting of Adverse Drug Experiences (I), Preparation of Investigational New Drug Products (Human and Animal) (I), Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (I), Prussian Blue for Treatment of Internal Contamination With Thallium or Radioactive Cesium (I), Psychoactive Drugs in Infants and Children -- Clinical Evaluation (I), Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs (I), Study of Drugs Likely to be Used in the Elderly (I), Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (I), Summary for New Drug and Antibiotic Applications -- Format and Content* (I), Systemic Lupus Erythematosus - Developing Drugs for Treatment (I), The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (I), Acne Vulgaris: Developing Drugs for Treatment (I), Allergic Rhinitis: Clinical Development Programs for Drug Products (I), Anti-Anginal Drugs -- Clinical Evaluation (I), Anti-Arrhythmic Drugs -- Clinical Evaluation, Antihypertensive Drugs -- Clinical Evaluation, Assessment of Abuse Potential of Drugs (I), Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment (I), Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA) (I), Clinical Evaluation of Drugs for the Treatment of Congestive Heart Failure (I), Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics, Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees (I), Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination, Combination Products Timeliness of Premarket Reviews (I), Computerized Systems Used in Clinical Trials (I), Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations, Developing Products for Weight Management Revision 1 (I), Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis (I), Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention (I), Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals, Estrogen and Estrogen/ Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms - Recommendations for Clinical Evaluation (I), Exercise-Induced Bronchospasm (EIB) - Development of Drugs to Prevent EIB (I), Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention (I), Inhalation Drug Products Packaged in Semipermeable Container Closure Systems (I), Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND (I), Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs, Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis (I), OTC Treatment of Herpes Labialis with Antiviral Agents (I), Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval, Pediatric Oncology Studies in Response to a Written Request (I), Preparation of IND Applications for New Drugs Intended for the Treatment of HIV-Infected Individuals, Qualification Process for Drug Development Tools (I), Recommendations for Complying with the Pediatric Rule (I), Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment (I), Standards for Clinical Trial Imaging Endpoints, Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials, The Use of Clinical Holds Following Clinical Investigator Misconduct (I), Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro (I), Exposure-Response Relationships - Study Design, Data Analysis, and Regulatory Applications (I), Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application (I), In Vivo Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling (I), Pharmacokinetics in Patients With Impaired Hepatic Function; Study Design, Data Analysis, and Impact on Dosing and Labeling (I), Pharmacokinetics in Patients with Impaired Renal Function: Study Design, Data Analysis, and Impact on Dosing and Labeling (I), Clinical Lactation Studies - Study Design, Data Analysis and Recommendations for Labeling, Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies, Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations, General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products (I), Pharmacokinetics in Pregnancy - Study Design, Data Analysis, and Impact on Dosing and Labeling (I), Submission Documentation for Sterilization Process Validation Applications for Human and Veterinary Drug Products (I), Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes (I), Application User Fees for Combination Products, Combination Products Timeliness of Premarket Reviews; Dispute Resolution (I), Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies (I), A Review of FDA's Implementation of the Drug Export Amendments of 1986 (I), Bar Code Label Requirements - Questions and Answers (Revised) (I), Current Good Manufacturing Practice for Phase 1 Investigational Drugs (I), Current Good Manufacturing Practice for Positron Emission Tomography Drug Products (I), Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products, Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (I), Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practices (I), General Principles of Process Validation (I), Good Laboratory Practice Regulations -- Questions and Answers (I), Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities (I), Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production (I), Marketed Unapproved Drugs;Compliance Policy Guide (I), Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography, Monitoring of Clinical Investigations (I), Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment (I), Part 11, Electronic Records, Electronic Signatures - Scope and Application, PET Drugs Current Good Manufacturing Practice (CGMP), Pharmaceutical Components at Risk for Melamine Contamination (I), Pharmacy Compounding --Compliance Policy Guide (I), Possible Dioxin/PCB Contamination of Drug and Biological Products (I), Prescription Drug Marketing Act Regulations for Donation of Prescription Drug Samples to Free Clinics (I), Process Analytical Technology -- A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance (I), Process Validation: General Principles and Practices, Pyrogen and Endotoxins Testing: Questions and Answers, Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (I), Sterile Drug Products Produced by Aseptic Processing (I), Testing of Glycerin for Diethylene Glycol (I), The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Good Manufacturing Practice (CGMP) (I), Comparability Protocols -- Protein Drug Products and Biological Products -- Chemistry, Manufacturing, and Controls Information (I), Current Good Manufacturing Practices for Combination Products (I), Current Good Manufacturing Practices for Medical Gases (3rd Revision) (I), Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide, Guidance for IRBs, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (I), Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality, Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting, Availability (I), Manufacturing, Processing or Holding of Active Pharmaceutical Ingredients (I), Powder Blends and Finished Dosage Units--Stratified In-Process Dosage Unit Sampling and Assessment (I), Repackaging of Solid Oral Dosage Form Drug Products, Drug Safety Information--Food and Drug Administration's Communication to the Public (I), Drug-Induced Liver Injury: Premarketing Clinical Evaluation (I), Medication Guides--Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies, Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic, Postmarketing Studies and Clinical Trials--Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act, Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets, Classifying Significant Posmarketing Drug Safety Issues, Drug Safety Information -- FDA's Communication to the Public, Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (I), Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act, Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies (I), Providing Electronic Submissions in Electronic Format - ANDAs (I), Providing Regulatory Submissions in Electronic Format -- Content of Labeling (I), Providing Regulatory Submissions in Electronic Format -- Human Pharmaceutical Product Applications and Related Submissions (I), Regulatory Submissions in Electronic Format; General Considerations (I), Regulatory Submissions in Electronic Format; NDAs (I), SPL Standard for Content of Labeling Technical Qs & As (I), Compliance Policy on Reporting Drug Sample Distribution Information, Providing Regulatory Submissions in Electronic Format -- Annual Reports for New DrugApplications and Abbreviated New Drug Applications (I), Providing Regulatory Submissions in Electronic Format--General Considerations (I), Providing Regulatory Submissions in Electronic Format - Postmarketing Expedited Safety Reports (I), Providing Regulatory Submissions in Electronic Format - Postmarketing Individual Case Safety Reports (I), Providing Regulatory Submissions in Electronic Format -- Postmarketing Periodic Adverse Drug Experience Reports (I), Providing Regulatory Submissions in Electronic Format - Prescription Drug Advertising and Promotional Labeling (I), Providing Regulatory Submissions in Electronic Format--Receipt Date (I), Providing Submissions in Electronic Format -- Standardized Study Data, 180-Day Exclusivity When Multiple Abbreviated New Drug Applications Are Submitted on the Same Day (I), Abbreviated New Drug Applications: Impurities in Drug Products, Alternate Source of Active Pharmaceutical Ingredients in Pending ANDAs (I), ANDAs: Impurities in Drug Substances; Chemistry, Manufacturing and Controls Information (I), ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing and Controls Information (I), Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (I), Handling and Retention of Bioavailability and Bioequivalence Testing Samples (I), Individual Product Bioequivalence Recommendations - List of Product Bioequivalence Recommendations (I), Letter announcing that the OGD will now accept the ICH long-term storage conditions as well as the stability studies conducted in the past (I), Letter describing efforts by the CDER & the ORA to clarify the responsibilities of CDER chemistry review scientists and ORA field investigators in the new & abbreviated drug approval process in order to reduce duplication or redundancy in the process (I), Letter on incomplete Abbreviated Applications, Convictions Under GDEA, Multiple Supplements, Annual Reports for Bulk Antibiotics, Batch Size for Transdermal Drugs, Bioequivalence Protocols, Research, Deviations from OGD Policy (I), Letter on the provision of new information pertaining to new bioequivalence guidelines and refuse-to-file letters (I), Letter on the provision of new procedures and policies affecting the generic drug review process (I), Letter on the request for cooperation of regulated industry to improve the efficiency and effectiveness of the generic drug review process, by assuring the completeness and accuracy of required information and data submissions (I), Letter on the response to 12/20/84 letter from the Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration Act (I), Letter to all ANDA and AADA applicants about the Generic Drug Enforcement Act of 1992 (GDEA), and the Office of Generic Drugs intention to refuse-to-file incomplete submissions as required by the new law (I), Letter to regulated industry notifying interested parties about important detailed information regarding labeling, scale-up, packaging, minor/major amendment criteria, and bioequivalence requirements (I), Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications (I), Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing (I), Revising ANDA Labeling Following Revision of the RLD Labeling (I), Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (I), Variations in Drug Products that May Be Included in a Single ANDA (I), Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505 (b)(2) Applications Under Hatch Waxman, as Amended by the Medicare Prescription Drug Improvement, and Modernization Act of 2003 - Questions and Answers (I), Generic Drug User Fee Amendments of 2012: Questions and Answers, Self-Identification of Generic Drug Facilities, Sites, and Organizations, ANDAs: Stability Testing of Drug Substances and Products, Good Review Management Principles for Prescription Drug User Fee Act Products (I), Pharmacology/Toxicology Review Format (I), E1A - The Extent of Population Exposure to Assess Clinical Safety: for Drugs Intended for Long Term Treatment of Non-Life-Threatening Conditions (I), E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (I), E2B - Data Elements for Transmission of Individual Case Safety Reports (I), E2B(M) - Data Elements for Transmission of Individual Case Safety Reports (Revised) (I), E2B(M): Data Elements for Transmission of Individual Case Safety Reports -- Questions and Answers (Revision 2) (I), E2C - Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (I), E2C Addendum - Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (I), E3 - Structure and Content of Clinical Study Reports (I), E4 - Dose-Response Information to Support Drug Registration (I), E5 - Ethnic Factors in the Acceptability of Foreign Clinical Data (I), E5 - Ethnic Factors in the Acceptability of Foreign Clinical Data, Questions and Answers (I), E6 - Good Clinical Practice: Consolidated Guideline (I), E7 - Studies in Support of Special Populations: Geriatrics (I), E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers, E8 - General Considerations for Clinical Trials (I), E9 - Statistical Principles for Clinical Trials (I), E10 - Choice of Control Group and Related Issues in Clinical Trials (I), E11 - Clinical Investigation of Medicinal Products in the Pediatric Population (I), E14 - Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non Antiarrhythmic Drugs (I), E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non Antiarrhythmic Drugs.

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