Subjects: Data Collection and Government Regulation / Genre: Guideline - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Data Collection ✖ Subjects Government Regulation ✖ Genre Guideline ✖

1. E19: a selective approach to safety data collection in specific late-stage preapproval or post-approval clinical trials : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2022
Subject(s):: Clinical Trials as Topic
Data Collection
Government Regulation
Patient Safety
United States
United States. Food and Drug Administration

2. 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.

3. Real-world data: assessing registries to support regulatory decision-making for drug and biological products : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):: Biological Products
Data Collection
Decision Making
Drug Industry
Legislation, Drug
Government Regulation
Pharmaceutical Preparations
Registries
United States

4. Digital health technologies for remote data acquisition in clinical investigations: guidance for industry, investigators, and other stakeholders

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):: Data Collection
Digital Health
Equipment Design
Equipment Safety
Government Regulation
Medical Device Legislation
Remote Sensing Technology -- standards
United States