Annual status report information and other submissions for postmarketing requirements and commitments: using forms FDA 3988 and FDA 3989 : guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Forms as Topic Government Regulation Product Surveillance, Postmarketing United States United States. United States.
- Genre(s):
- Guideline Technical Report
- Abstract:
- This guidance is intended for applicants that are required to report annually on the status of postmarketing studies and clinical trials for human drug and biological products under section 506B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356b) and its implementing regulations at 21 CFR 314.81(b)(2)(vii) and 601.70. In other words, this guidance is intended for applicants that are required by statute or regulation, or that have agreed in writing, to conduct postmarketing studies or clinical trials concerning a product’s clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology as postmarketing requirements (PMRs) or postmarketing commitments (PMCs). This guidance describes the purpose and content of Form FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and Biologics, and Form FDA 3989, PMR/PMC Annual Status Report for Drugs and Biologics; when to use these forms; and how to submit these forms. Submission of completed Form FDA 3989 will meet the annual status reporting requirements for postmarketing studies or clinical trials described in section 506B of the FD&C Act and its implementing regulations. This guidance does not apply to postmarketing studies or clinical trials that are not subject to the reporting requirements of section 506B of the FD&C Act. For example, the guidance does not apply to voluntary studies or clinical trials conducted by an applicant or on an applicant’s behalf that are neither required nor agreed upon in writing. This guidance also does not apply to chemistry, manufacturing, and controls (CMC) commitments and stability studies that are not subject to section 506B requirements. The information in this guidance does not replace the information provided in the guidance for industry Reports on the Status of Postmarketing Study Commitments - Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (February 2006) and the draft guidance for industry Postmarketing Studies and Clinical Trials - Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (October 2019). Forms FDA 3988 and FDA 3989 do not replace existing requirements to submit other FDA forms, such as the Form FDA 356h, Application to Market a New or Abbreviated New Drug or Biologic for Human Use, or the Form FDA 2252, Transmittal of Annual Reports for Drugs and Biologics for Human Use. Forms FDA 3988 and FDA 3989 are not intended to accompany or replace any submissions related to postmarketing studies or clinical trials that are not subject to the reporting requirements of section 506B of the FD&C Act. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended,
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (10 pages))
- NLM Unique ID:
- 9918716786706676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918716786706676