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Start Over Collections Health Policy and Services Research ✖Remove constraint Collections: Health Policy and Services Research Subjects Government Regulation ✖Remove constraint Subjects: Government Regulation Publication Year 2000 to 2024 ✖Remove constraint Publication Year: <span class="from" data-blrl-begin="2000">2000</span> to <span class="to" data-blrl-end="2024">2024</span>

561. Institutional review board (IRB) review of individual patient expanded access submissions for investigational drugs and biological products: guidance for IRBs and clinical investigators

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
Subject(s):
Biological Products
Compassionate Use Trials
Drug Industry
Drugs, Investigational
Ethics Committees, Research
Government Regulation
United States

562. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process": guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 8, 2023
Subject(s):
Biological evaluation of medical devices
Device Approval
Equipment and Supplies -- adverse effects
Government Regulation
Guidelines as Topic
United States

567. Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):
Biological Products
Clinical Trials as Topic
Data Analysis
Decision Making
Drug Approval
Drug Industry
Drug and Narcotic Control
Government Regulation
United States
United States.

568. Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies : guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):
Counterfeit Drugs
Drug Industry
Drug and Narcotic Control
Fraud
Government Regulation
Substandard Drugs
United States
United States.

569. Hospital mergers and public accountability: Tennessee and Virginia employ a certificate of public advantage

Author(s):
Brown, Erin C. Fuse, author
Publication:
New York, NY : Milbank Memorial Fund, September 2018
Subject(s):
Antitrust Laws
Health Facility Merger -- organization & administration
Social Responsibility
Government Regulation
Health Policy
Health Services Accessibility
Medicaid
Public Opinion
Quality of Health Care
State Government
Humans
Tennessee
United States
Virginia
United States. Federal Trade Commission.

570. Voluntary consensus standards recognition program for regenerative medicine therapies: guidance for industry

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023
Subject(s):
Drug Industry
Government Regulation
Reference Standards
Regenerative Medicine -- legislation & jurisprudence
Regenerative Medicine -- standards
Voluntary Programs
United States
Center for Biologics Evaluation and Research (U.S.)