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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

141. 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.

142. 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.

144. 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.

147. 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.

148. 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.

149. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, July 2020
Subject(s):
Biological Products
Tissues
Cell- and Tissue-Based Therapy
Tissue Transplantation
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

150. Cancer clinical trial eligibility criteria: minimum age considerations for inclusion of pediatric patients : guidance for industry and IRBs

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