Drugs
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Postmarketing Safety Reporting Requirements for Drug and Biologic Products
This website serves as a resource to applicants, licensed manufacturers, packers, distributors and responsible persons subject to FDA’s requirements for postmarketing safety reporting for human drugs and biological products under 21 CFR §§ 310.305, 314.80, 314.98, 600.80, 1271.350 and Section 760 of the Food Drug and Cosmetic Act (FDCA).
Regulations and Laws:
| Regulation or Law | Product |
|---|---|
| 21 CFR § 310.305 | Prescription drugs marketed for human use without approved new |
| 21 CFR § 314.80 | Drugs with approved new drug applications (NDAs) |
| 21 CFR § 314.98 | Drugs with approved abbreviated new drug applications (ANDAs) |
| 21 CFR § 600.80 | Biologics with approved biologics license applications (BLAs) |
| 21 CFR § 1271.350 | Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) |
| Section 760 of the FDCA | Nonprescription human drug products marketed without an |
Guidances:
- 2001 Draft Guidance: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines (PDF - 375KB)
- 1992 Guideline for Postmarketing Reporting of Adverse Drug Experiences (PDF - 4MB)
- 1997 Guidance: Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (PDF - 95KB)
- 2009 Guidance: Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed without an Approved Application (PDF - 298KB)
- 2012 Guidance: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic (PDF - 218KB)
- 2008 Draft Guidance: Providing Regulatory Submissions in Electronic Format--Postmarketing Individual Case Safety Reports (PDF - 107KB)
- 2005 Guidance: MedWatch Form 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Proposed Rules:
- 2003 Safety Reporting Requirements for Human Drug and Biological Products Proposed Rule
- 2009 Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements Proposed Rule
- 2009 Postmarketing Safety Reporting for Combination Products
Other Resources:
- Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
- Adverse Event Reporting System (AERS)
AERS is FDA’s national safety surveillance database for drug and therapeutic biologic products. AERS collects information about adverse events, medication errors and product problems that occur after the administration of these products. - Vaccine Adverse Event Reporting System (VAERS)
VAERS is a national vaccine safety surveillance program co-sponsored by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).
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