Subjects: Government Regulation and United States. / Recently Added: Within 6 Months - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Government Regulation ✖ Subjects United States. ✖ Recently Added Within 6 Months ✖

1. Breakthrough Devices Program: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2023
Subject(s):: Data Collection
Device Approval
Government Regulation
Medical Device Legislation
United States
United States.
United States.

2. 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.

3. Enhanced drug distribution security at the package level under the Drug Supply Chain Security Act: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):: Drug Industry
Drug and Narcotic Control
Drug Packaging
Government Regulation
Security Measures
United States
United States.
United States.

4. Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):: Biological Products
Clinical Trials as Topic
Data Analysis
Decision Making
Drug Approval
Drug Industry
Drug and Narcotic Control
Government Regulation
United States
United States.

5. Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):: Counterfeit Drugs
Drug Industry
Drug and Narcotic Control
Fraud
Government Regulation
Substandard Drugs
United States
United States.

6. Notifying FDA of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, November 17, 2023
Subject(s):: Correspondence as Topic
Device Approval
Government Regulation
Manufacturing Industry
United States
United States.

7. CARES Act: experts identified safeguards to help selected HHS agencies protect against potential political interference : report to congressional requesters

Publication:: Washington, DC : United States Government Accountability Office, September 2023
Subject(s):: Government Regulation
Legislation, Medical
Politics
Professional Misconduct
United States
United States.
United States. Department of Health and Human Services

8. Medicare cognitive assessments: utilization tripled between 2018 and 2022, but challenges remain : report to congressional committees

Publication:: Washington, DC : United States Government Accountability Office, December 2023
Subject(s):: Alzheimer Disease
Government Regulation
Healthcare Disparities
Medicare
Mental Status and Dementia Tests -- statistics & numerical data
Neurocognitive Disorders
United States
United States.
Centers for Medicare & Medicaid Services (U.S.)