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Start Over Subjects Guidelines as Topic ✖Remove constraint Subjects: Guidelines as Topic Copyright Public domain ✖Remove constraint Copyright: Public domain 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>

1. FDA should further integrate its review of cybersecurity into the premarket review process for medical devices

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2018
Subject(s):
Computer Security
Device Approval -- standards
Equipment and Supplies -- standards
Equipment Safety -- standards
Computer Communication Networks -- standards
Guidelines as Topic
Software -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters

Publication:
Washington, D.C. : U.S. Government Accountability Office, January 2017
Subject(s):
Anti-Bacterial Agents -- therapeutic use
Drug Approval
Drug Industry
Drugs, Investigational
Investigational New Drug Application
Drug Resistance, Bacterial
Guidelines as Topic
Humans
United States
United States. Food and Drug Administration.

4. Standards development and the use of standards in regulatory submissions reviewed in the Center for Biologics Evaluation and Research

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, March 2019
Subject(s):
Guidelines as Topic
Consensus
Device Approval
Drug Approval
Government Agencies
Voluntary Programs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Center for Biologics Evaluation and Research (U.S.)