FDA Issues Final Guidance on Electronic Postmarketing Safety Reports

FDA has issued the final guidance, Providing Submissions in Electronic Format– Postmarketing Safety Reports, the last 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 Center for Biologics Evaluation and Research (CBER).

The guidance is intended for any party with postmarketing safety reporting responsibilities for approved and unapproved human drug products and licensed biological products, excluding vaccines. The guidance also provides recommendations on how to submit postmarketing safety reports that FDA can process, review, and archive. A revised draft version of this guidance was issued in June 2014, and minimal changes were made in the final guidance.

The guidance provides general information on the electronic submission of postmarketing safety reports under the following provisions, according to FDA; “21 CFR [Code of Federal Regulations] 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); and 21 CFR 310.305 (regarding prescription drug products marketed for human use without approved NDAs or ANDAs, including prescription drug products that are compounded.”