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331. 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.

332. 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.

333. 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.

334. 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.

335. Food safety: federal efforts to manage the risk of arsenic in rice : report to the Ranking Member, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, Committee on Appropriations, House of Representatives

Publication:
Washington, DC : United States Government Accountability Office, March 2018
Subject(s):
Arsenic
Food Contamination -- prevention & control
Food Safety
Oryza
United States
United States. Department of Agriculture.
United States. Food and Drug Administration.

337. Keeping America's food safe: a blueprint for fixing the food safety system at the U.S. Department of Health and Human Services

Author(s):
Levi, Jeffrey, author
Segal, Laura M., author
Vinter, Serena, author
Publication:
Washington, DC : Trust for America's Health, March 2009
Subject(s):
Consumer Product Safety
Food Industry -- organization & administration
Organizational Policy
Health Care Reform
Leadership
Legislation, Food
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

338. One percent of drugs with Medicaid reimbursement were not FDA-approved

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, May 2019
Subject(s):
Drug Approval
Insurance, Health, Reimbursement -- economics
Insurance, Health, Reimbursement -- statistics & numerical data
Medicaid -- economics
Medicaid -- statistics & numerical data
Economics, Pharmaceutical
Fraud -- prevention & control
Prescription Drugs -- economics
Humans
United States
United States. Food and Drug Administration.

339. Most hospitals obtain compounded drugs from outsourcing facilities, which must meet FDA quality standards

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, June 2019
Subject(s):
Drug Compounding -- standards
Medicare
Outsourced Services
Purchasing, Hospital
Quality Control
Chemistry, Pharmaceutical -- standards
Humans
United States
United States. Food and Drug Administration.

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