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141. FDA medical device reviews: evaluation is needed to assure requests for additional information follow a least burdensome approach : report to Congressional requestors

Publication:
Washington, DC : United States Government Accountability Office, December 2017
Subject(s):
Device Approval -- standards
Equipment Safety
Federal Government
Forecasting
Government Regulation
Inservice Training
Humans
United States
United States. Food and Drug Administration.

142. Generic drugs: FDA should make public its plans to issue and revise guidance on nonbiological complex drugs : report to Congressional requesters

Publication:
Washington, DC : United States Government Accountability Office, December 2017
Subject(s):
Drug Approval
Drugs, Generic
Therapeutic Equivalency
Chemistry, Pharmaceutical
Doxorubicin
Drug Development
Enoxaparin
Glatiramer Acetate
Gluconates
Propofol
Humans
United States
United States. Food and Drug Administration.

143. Implantable devices: regulatory framework and reform options

Author(s):
Lind, Keith D., author
Publication:
Washington, DC : AARP Public Policy Institute, August 2017
Subject(s):
Government Regulation
Prostheses and Implants -- adverse effects
Prostheses and Implants -- standards
Clinical Trials as Topic
Device Approval
Equipment Failure
Equipment Safety
Product Surveillance, Postmarketing
Registries
Humans
United States
United States. Food and Drug Administration.

144. Exploring the role of cost-benefit analysis in government regulations

Publication:
Washington, D.C. : AARP Public Policy Institute, c2007
Subject(s):
Health Policy -- economics
Cost-Benefit Analysis -- methods
Government Regulation
Federal Government
Decision Making
Delivery of Health Care
Government Agencies
Public Health
Quality-Adjusted Life Years
Safety
Value of Life
Humans
United States
United States. Environmental Protection Agency.
United States. Food and Drug Administration.

146. A sense of déjà vu: the debate surrounding state biosimilar substitution laws

Author(s):
Purvis, Leigh, author
Publication:
Washington, D.C. : AARP Public Policy Institute, September 2014
Subject(s):
Biological Products -- economics
Biological Products -- therapeutic use
Biosimilar Pharmaceuticals -- economics
Biosimilar Pharmaceuticals -- therapeutic use
Drug Costs
Drug Substitution
Legislation, Drug
Drugs, Generic -- economics
Federal Government
State Government
Humans
United States
United States. Food and Drug Administration.
United States.

149. Pathological complete response in neoadjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval

Publication:
[Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):
Breast Neoplasms
Clinical Trials as Topic
Neoadjuvant Therapy
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

150. Enforcement policy for viral transport media during the Coronavirus disease 2019 (COVID-19) public health emergency: guidance for commercial manufacturers, clinical laboratories, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, Office of Product Evaluation and Quality, July 2020
Subject(s):
Culture Media
Specimen Handling
Transportation
Virus Diseases
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

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