Mandatory Reporting - Drug/Biologic/Human Cell, Tissues and Cellular and Tissue-Based Product Manufacturers, Distributors, and Packers
Mandatory MedWatch Reporting Form and Instructions
- Visit the MedWatch Download Forms page to get copies of the Mandatory Reporting
FDA Form 3500A in PDF format.
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
Guidance for Industry
Guidance for FDA Field Staff
International Conference on Harmonization of Technical Requirements for Registration
of Pharmaceuticals for Human Use (ICH)
The initiatives that directly affect postmarketing surveillance are:
- MedDRA Term Selection: Points to Consider - an ICH-Endorsed Guide for MedDRA Users
[External Link]
- M1 MedDRA (Medical Dictionary for Regulatory
Activities)
- M2 ESTRI (Electronic Standards for the
Transfer of Regulatory Information)
- E2A
(Clinical
Safety Data Management)
- E2B
(Guidance
On Data Elements For Transmission of Individual Case Safety Reports)
- E2BM
(Guidance
on Data Elements for Transmission of Individual Case Safety Reports)
- E2C
PSUR
(Periodic Safety Update Report)
Federal Register Publications Related to Postmarketing
Reporting
-
- [External link to the Federal Register.]
Most documents listed here may be downloaded in TEXT and/or PDF format.
- 5/04/01: (
PDF format)
Providing Regulatory Submissions in Electronic Format - Postmarketing
Expedited Safety Reports; Availability - NOTICE
[Docket No. O1D-0185] Vol. 66, No. 87, pg. 22585 - 22586
- 3/12/01: (
PDF format)
Postmarketing Safety Reporting for Human Drug and Biological
Products Including Vaccines; Availability - NOTICE
[Docket No. O1D-0056] Vol. 66, No. 48, pg. 14391 - 14392
- 11/05/98: (TEXT format
or
PDF format)
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
- 10/07/97: (TEXT format
or
PDF format)
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
- 06/25/97: (TEXT format
or
PDF format)
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
- 05/19/97: (TEXT format
or
PDF format)
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
- 10/1/96:
(TEXT format)
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
- 04/03/95:
(TEXT format
or
PDF format)
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
- 03/01/95: (TEXT format or
PDF format)
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
- 10/27/94: (TEXT format)
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
- 10/27/94: (TEXT format)
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
- 06/03/93:
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
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