The US Food and Drug Administration (FDA) regulates postmarketing safety reporting for human drugs and biological products through statutory and regulatory requirements, electronic reporting systems and compliance programmes.
Core official resources
- Postmarketing Adverse Event Reporting Compliance Program — FDA compliance resource covering company postmarketing adverse-event reporting and submission routes.
- FDA Adverse Event Monitoring System (AEMS) — the current FDA adverse-event monitoring system, formerly known as FAERS.
- MedWatch — FDA safety information and voluntary adverse-event reporting programme.
- Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines — an older draft guidance that remains a useful pointer to underlying postmarketing reporting regulations; its draft status must be recognised.
Practical use
Use current FDA regulations and current FDA reporting instructions as the controlling sources. Historical documents and the former term FAERS remain useful for retrieval but should not be mistaken for current system naming.