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Start Over Collections Health Policy and Services Research ✖Remove constraint Collections: Health Policy and Services Research Subjects United States. Food and Drug Administration. ✖Remove constraint Subjects: United States. Food and Drug Administration. Dates by Range 2000 and later ✖Remove constraint Dates by Range: 2000 and later Publication Year 2017 to 2019 ✖Remove constraint Publication Year: <span class="from" data-blrl-begin="2017">2017</span> to <span class="to" data-blrl-end="2019">2019</span>

131. 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.

132. 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.

133. 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.

134. The effect of Medicare Part D on evergreening, generic entry, and drug prices

Author(s):
Sanzenbacher, Geoffrey T., author
Wettstein, Gal, author
Publication:
Chestnut Hill, MA : Center for Retirement Research at Boston College, May 2019
Subject(s):
Drug Costs
Drugs, Generic -- economics
Medicare Part D -- economics
Patents as Topic
Aged
Drug Industry -- economics
Economics, Pharmaceutical
Humans
United States
United States. Food and Drug Administration.
Medical Expenditure Panel Survey (U.S.)

136. Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 1, 2019
Subject(s):
Anti-Infective Agents
Device Approval
Drug Approval
Drug Development
Microbial Sensitivity Tests
Drug Industry
Biotechnology
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

139. Intent to exempt certain unclassified medical devices from premarket notification requirements: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, June 14, 2019
Subject(s):
Device Approval
Equipment and Supplies -- classification
Gastroenterology -- instrumentation
Gynecology
Obstetrics -- instrumentation
Otolaryngology -- instrumentation
Physical and Rehabilitation Medicine -- instrumentation
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.