Copyright: Public domain / Recently Added: Within 6 Months / Dates by Range: 2000 and later - Digital Collections - National Library of Medicine Search Results

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1. Adjusting for covariates in randomized clinical trials for drugs and biological products: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
Subject(s):: Biological Products
Drug Industry
Government Regulation
Pharmaceutical Preparations
Randomized Controlled Trials as Topic
United States

2. Testing of glycerin, propylene glycol, maltitol solution, hydrogenated starch hydrolysate, sorbitol solution, and other high-risk drug components for diethylene glycol and ethylene glycol: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
Subject(s):: Drug Contamination
Drug Industry
Drug-Related Side Effects and Adverse Reactions
Ethylene Glycols
Glycerol
Government Regulation
Propylene Glycol
Sorbitol
United States

3. Q9(R1): : quality risk management : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
Subject(s):: Drug Development
Drug Industry
Government Regulation
Risk Management
United States

4. Smoking cessation and related indications: developing nicotine replacement therapy drug products : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
Subject(s):: Drug Development
Government Regulation
Nicotine Chewing Gum
Smoking Cessation
Smoking Cessation Agents
Tobacco Use Cessation Devices
United States

5. S12 nonclinical biodistribution considerations for gene therapy products: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
Subject(s):: Genetic Therapy
Government Regulation
Research Design
United States

6. Peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, April 14, 2023
Subject(s):: Angioplasty, Balloon, Coronary
Cardiac Catheters
Device Approval
Government Regulation
United States

7. A risk-based approach to monitoring of clinical investigations questions and answers: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2023
Subject(s):: Clinical Trials Data Monitoring Committees
Clinical Trials as Topic
Government Regulation
Research Design
Research Personnel
United States

8. Cybersecurity in medical devices: refuse to accept policy for cyber devices and related systems under section 524B of the FD&C Act : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, March 30, 2023
Subject(s):: Computer Security -- legislation & jurisprudence
Device Approval
Equipment Safety
Government Regulation
United States
United States.

9. Soft (hydrophilic) daily wear contact lenses: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, March 28, 2023
Subject(s):: Contact Lenses, Hydrophilic -- standards
Device Approval
Equipment Safety
Government Regulation
United States

10. General considerations for animal studies intended to evaluate medical devices: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, March 28, 2023
Subject(s):: Animal Experimentation
Animal Welfare
Animals, Laboratory
Device Approval
Equipment Safety
Equipment and Supplies
Government Regulation
United States

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