Subjects: Product Surveillance, Postmarketing - Digital Collections - National Library of Medicine Search Results

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NLM Digital Collections

Start Over Subjects Product Surveillance, Postmarketing

1. Postmarketing adverse event reporting for medical products and dietary supplements during a pandemic

Publication:: Silver Spring, MD : Office of Counterterrorism and Emerging Threats, May 2020
Subject(s):: Dietary Supplements -- adverse effects
Drug-Related Side Effects and Adverse Reactions
Equipment Design -- adverse effects
Equipment Safety
Product Surveillance, Postmarketing
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

2. Long term follow-up after administration of human gene therapy products

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020
Subject(s):: Genetic Therapy -- adverse effects
Product Surveillance, Postmarketing
Drug Evaluation, Preclinical
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3. Providing submissions in electronic format: postmarketing safety reports

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):: Drug Approval
Electronic Mail
Product Surveillance, Postmarketing
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4. Medical devices

Author(s):: White, Robert S., (Compliance Attorney and member of the Oklahoma Bar), author
Publication:: [Toronto, Ontario] : Thomson Reuters, 19-December-2022
Subject(s):: Device Approval
Product Surveillance, Postmarketing
Equipment Safety
Medical Device Recalls -- legislation & jurisprudence
United States
United States. Food and Drug Administration

5. Annual status report information and other submissions for postmarketing requirements and commitments: using forms FDA 3988 and FDA 3989 : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
Subject(s):: Forms as Topic
Government Regulation
Product Surveillance, Postmarketing
United States
United States.
United States.

6. Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, October 7, 2022
Subject(s):: Device Approval -- legislation & jurisprudence
Government Regulation
Product Surveillance, Postmarketing
United States
United States. Food and Drug Administration

7. The practicing physician and clinical research

Publication:: [Bethesda, Md. : Medical Arts and Photography Branch, National Institutes of Health, 1981]
Subject(s):: Biomedical Research
Ambulatory Care
Clinical Trials as Topic
Product Surveillance, Postmarketing

8. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, August 31, 2017
Subject(s):: Equipment and Supplies
Equipment Safety
Evidence-Based Medicine
Product Surveillance, Postmarketing
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

9. Fraud fighters

Publication:: [Culver City, CA] : RKO Pathe, c1949
Subject(s):: Drug Approval
Fraud -- prevention & control
Advertising
Product Surveillance, Postmarketing
United States. Food and Drug Administration