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5021. Process to request a review of FDA's decision not to issue certain export certificates for devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, November 14, 2019
Subject(s):
Commerce -- legislation & jurisprudence
Equipment and Supplies -- standards
Device Approval -- legislation & jurisprudence
Equipment Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

5022. Smallpox (variola virus) infection: developing drugs for treatment or prevention

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2019
Subject(s):
Clinical Trials as Topic
Drug Development -- standards
Smallpox -- drug therapy
Smallpox -- prevention & control
Antiviral Agents -- pharmacology
Antiviral Agents -- therapeutic use
Drug Evaluation, Preclinical
Emergencies
Investigational New Drug Application
Models, Animal
Orthopoxvirus
Public Health
Research Design
Safety
Toxicity Tests
Variola virus
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5023. Compliance policy for limited modifications to certain marketed tobacco products

Publication:
Silver Spring, MD : Center for Tobacco Products, November 2019
Subject(s):
Electronic Nicotine Delivery Systems -- standards
Nicotine -- adverse effects
Tobacco Products -- adverse effects
Child
Consumer Product Safety
Equipment Failure
Product Packaging
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5024. Adaptive designs for clinical trials of drugs and biologics

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2019
Subject(s):
Adaptive Clinical Trials as Topic -- standards
Investigational New Drug Application
Adaptive Clinical Trials as Topic -- ethics
Biological Products
Drugs, Investigational
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5025. Considerations for the development of dried plasma products intended for transfusion

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, December 2019
Subject(s):
Blood Transfusion -- standards
Device Approval
Drug Approval
Drug Development -- standards
Plasma
Plasma -- microbiology
Product Packaging
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5026. Food labeling: serving sizes of foods that can reasonably be consumed at one eating occasion, reference amounts customarily consumed, serving size-related issues, dual-column labeling, and miscellaneous topics

Publication:
Silver Spring, MD : Food and Drug Administration, Center for Food Safety and Applied Nutrition, December 2019
Subject(s):
Diet, Healthy
Food Labeling -- standards
Portion Size -- standards
Product Labeling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5027. Enforcement priorities for electronic nicotine delivery systems (ENDS) and other deemed products on the market without premarket authorization

Publication:
Silver Spring, MD : Center for Tobacco Products, January 2020
Subject(s):
Commerce -- legislation & jurisprudence
Electronic Nicotine Delivery Systems -- standards
Tobacco Products -- legislation & jurisprudence
Tobacco Products -- standards
Adolescent
Government Regulation
Product Labeling
Vaping -- prevention & control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.