21 CFR 314.80 - Postmarketing Reporting of Adverse Drug Experiences

What it says

Applicants with approved applications must review adverse drug experience information from any source, develop written procedures for surveillance, receipt, evaluation and reporting, submit serious and unexpected adverse experiences as 15-day Alert reports, submit periodic reports on the schedule required, and keep records for the required period.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• A complaint about a product can also be an adverse event report, so quality and pharmacovigilance functions must share information.
• Written procedures are expected, and they should cover how information from any source is captured and assessed.
• Timelines are strict, with serious and unexpected events requiring prompt submission.

What FDA inspectors look for

• Whether written procedures for adverse experience handling exist and are followed.
• Whether serious and unexpected events were reported within the required time.
• Whether records of reports and follow-up are maintained.

Related regulations