Providing Submissions in Electronic Format — Postmarketing Safety Reports

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 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