Subjects: Clinical Studies as Topic and United States. Food and Drug Administration / Copyright: Public domain - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Clinical Studies as Topic ✖ Subjects United States. Food and Drug Administration ✖ Copyright Public domain ✖

1. General clinical pharmacology considerations for neonatal studies for drugs and biological products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Biological Products
Clinical Studies as Topic
Drug Development
Government Regulation
Infant Health
Pharmacology, Clinical
United States
United States. Food and Drug Administration

2. Procedures for handling post-approval studies imposed by premarket approval application order: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, October 7, 2022
Subject(s):: Clinical Studies as Topic
Device Approval
Government Regulation
United States
United States. Food and Drug Administration

3. Human gene therapy for neurodegenerative diseases: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, October 2022
Subject(s):: Clinical Studies as Topic
Genetic Therapy -- legislation & jurisprudence
Government Regulation
Neurodegenerative Diseases -- therapy
United States
United States. Food and Drug Administration

4. Patient engagement in the design and conduct of medical device clinical studies: guidance for industry, Food and Drug Administration staff, and other stakeholders

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, January 26, 2022
Subject(s):: Clinical Studies as Topic
Device Approval
Patient Participation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. Feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with Type 2 Diabetes Mellitus: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, May 6, 2022
Subject(s):: Clinical Studies as Topic
Diabetes Mellitus, Type 2 -- drug therapy
Glycemic Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration