Drug/Biologic/Human Cell, Tissues and Cellular and Tissue-Based Product Manufacturers, Distributors, and Packers
Information on mandatory reporting:
Applicable Regulations
You can search the FDA's CFR Title 21 Database for the latest regulations. The links below will take you directly to the relevant section.
- Drugs
- 21 CFR 310.305 -- Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
- 21 CFR 312.32 -- IND Safety Reports.
- 21 CFR 314.80 -- Postmarketing reporting of adverse drug experiences.
- Biologics
- 21 CFR 312.32 -- IND Safety Reports.
- 21 CFR 600.80 -- Postmarketing reporting of adverse experiences.
- 21 CFR 1271.350 -- Human Cells, Tissues, and Cellular and Tissue-Based Product Reporting
Guidance for Industry
- Guidances on Electronic Submissions
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Postmarketing Reporting of Adverse Experiences
Referencing FDA's MedWatch Program
Where to send mandatory reporting forms
MedWatch to Manufacturer Program
FDA Adverse Events Reporting System (FAERS)
- Postmarketing expedited and periodic individual case safety reports with and without attachments acceptable in electronic format without paper records (effective November 29, 2001)
Federal Register Publications Related to Postmarketing Reporting
[External link to the Federal Register Search]
- 5/04/2001: Providing Regulatory Submissions in Electronic Format - Postmarketing Expedited Safety Reports; Availability - NOTICE
[Docket No. O1D-0185] Vol. 66, No. 87, pg. 22585 - 22586 - 3/12/2001: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines; Availability - NOTICE
[Docket No. O1D-0056] Vol. 66, No. 48, pg. 14391 - 14392 - 11/05/1998: Electronic Reporting of Postmarketing Adverse Drug Reactions; Request for Comments - Advanced Notice of Proposed Rulemaking (21 CFR Parts 310, 314, and 600)
[Docket No. 98N-0750] Vol. 63, No. 214, pg. 59746 - 59750 - 10/07/1997: Expedited Safety Reporting Requirements for Human Drug and Biological Products - Final Rule (21 CFR Parts 20, 310, 312, 314, and 600)
[Docket No. 93N-0181] Vol. 62, No. 194, pg. 52237 - 52253 - 06/25/1997: Postmarketing Expedited Adverse Experience Reporting for Human Drug and Licensed Biological Products; Increased Frequency Reports - FINAL RULE (21 CFR Parts 310, 314, and 600)
[Docket No. 96N-0108] Vol. 62, No. 122, pg. 34166 - 34168 - 05/19/1997: International Conference on Harmonisation; Guideline on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs; Availability - NOTICE
[Docket No. 96D-0041] Vol. 62, No. 96, pg. 27470 - 27476 - 10/1/1996: International Conference on Harmonisation; Draft Guideline on Data Elements for Transmission of Individual Case Safety Reports; Availability - NOTICE
[Docket No. 96D-0236] Vol. 61, No.191, pg. 51287 - 51294 - 04/03/1995: Protecting the Identities of Reporters of Adverse Events and Patients; Preemption of Disclosure Rules - FINAL RULE (21 CFR Part 20)
[Docket No. 93N-0334] Vol. 60, No. 63, pg. 16962 - 16968 - 03/01/1995: International Conference on Harmonisation; Guideline on Clinical Safety Data Management; Definitions and Standards for Expedited Reporting; Availability - NOTICE
[Docket No. 93D-0203] Vol. 60, No. 40, pg. 11284 - 11287 - 10/27/1994: Adverse Experience Reporting Requirements for Licensed Biological Products - FINAL RULE (21 CFR Part 600)
[Docket No. 93N-0072] Vol. 59, No. 207, pg. 54034 - 54044 - 10/27/1994: Adverse Experience Reporting Requirements for Human Drug and Licensed Biological Products - PROPOSED RULE (21 CFR Parts 20, 310, 312, 314, and 600)
[Docket No. 93N-0181] Vol. 59, No. 207, pg. 54046 - 54064 - 06/03/1993: Form for Reporting Serious Adverse Events and Product Problems with Human Drug and Biological Products and Devices; Availability - NOTICE
[Docket No. 93N-0072] Vol. 58, No. 105, pg. 31596 - 31614