Providing submissions in electronic format: postmarketing safety reports
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. 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, April 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug Approval Electronic Mail Product Surveillance, Postmarketing United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- This guidance is one in a series of guidance documents intended to assist industry when making certain regulatory submissions in electronic format to FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This guidance provides general information on the electronic submission of postmarketing safety reports under the following provisions: (1) 21 CFR 314.80 and 314.98 (regarding products with approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs), respectively, including combination products or drug constituent parts with approved NDAs or ANDAs (2) 21 CFR 600.80 (regarding products with approved biologics license applications (BLAs), including combination products or biological product constituent parts with approved BLAs) (3) 21 CFR part 4, subpart B (requiring additional reports for combination products with approved NDAs, ANDAs, or BLAs) (4) 21 CFR 310.305 (regarding prescription drug products marketed for human use without approved NDAs or ANDAs, including prescription drug products that are compounded by facilities registered as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b)) (5) 21 CFR 329.100 and section 760 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379aa) (regarding nonprescription drug products marketed for human use without approved NDAs or ANDAs). However, this guidance does not apply to the following: (1) Vaccines (2) Whole blood or blood components (3) Combination products with a drug or biological product constituent part marketed under a device application (4) Lot distribution reports9 (5) Human cells, tissues, and cellular tissue-based products (HCT/Ps) regulated solely under section 361 of the Public Health Service Act10 The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (12 pages)).
- NLM Unique ID:
- 9918452381906676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918452381906676