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GUIDANCE DOCUMENT

Providing Submissions in Electronic Format — Postmarketing Safety Reports April 2022

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2001-D-0067
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

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:

  • 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 ANDAs2
  • 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

 

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2001-D-0067.

 
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