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Start Over Subjects United States. Food and Drug Administration. ✖Remove constraint Subjects: United States. Food and Drug Administration. Genre Technical Report ✖Remove constraint Genre: Technical Report Copyright Public domain ✖Remove constraint Copyright: Public domain

81. Emerging infectious diseases: actions needed to ensure improved response to Zika virus disease outbreaks : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives

Publication:
Washington, D.C. : U.S. Government Accountability Office, May 23, 2017
Subject(s):
Disease Outbreaks -- prevention & control
Mosquito Control
Zika Virus Infection -- epidemiology
Zika Virus Infection -- prevention & control
Zika Virus Infection -- transmission
Federal Government
State Government
Zika Virus Infection -- diagnosis
Humans
United States
United States. Food and Drug Administration.
Centers for Disease Control and Prevention (U.S.)

82. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 8 (R1) : sterility test general chapter

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):
Chemistry, Pharmaceutical -- standards
Drug Approval
Pharmacopoeias as Topic -- standards
Sterilization
Congresses as Topic
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

83. Classification of products as drugs and devices & additional product classification issues: final guidance : guidance for industry and FDA staff

Publication:
Silver Spring, MD : Office of Combination Products, Food and Drug Administration, September 2017
Subject(s):
Biological Products -- classification
Classification -- methods
Equipment and Supplies -- classification
Pharmaceutical Preparations -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

84. Advancement of emerging technology applications for pharmaceutical innovation and modernization

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):
Biomedical Technology -- standards
Drug Industry -- standards
Inventions
Quality Assurance, Health Care
Quality Improvement
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

85. Compliance policy for required warning statements on small-packaged cigars

Publication:
Silver Spring, MD : Center for Tobacco Products, Food and Drug Administration, September 2017
Subject(s):
Product Labeling -- standards
Product Packaging -- standards
Tobacco Products -- standards
Guideline Adherence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

86. Center for Devices and Radiological Health appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, Maryland] : Center for Devices and Radiological Health, September 29, 2017
Subject(s):
Device Approval -- standards
Documentation -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

87. Developing and responding to deficiencies in accordance with the least burdensome provisions: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 29, 2017
Subject(s):
Device Approval -- standards
Communication
Documentation -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

88. Requests for feedback on medical device submissions: the pre-submission program and meetings with Food and Drug Administration staff : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, Maryland] : Center for Devices and Radiological Health, September 29, 2017
Subject(s):
Device Approval -- standards
Clinical Protocols
Research Design
Telecommunications
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

89. Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017
Subject(s):
Clinical Laboratory Techniques
Device Approval -- standards
Diagnostic Test Approval -- standards
In Vitro Techniques -- standards
Reagent Kits, Diagnostic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

90. Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017
Subject(s):
Data Display -- standards
Image Processing, Computer-Assisted -- standards
Radiology Information Systems -- standards
Device Approval -- standards
Product Labeling -- standards
Software -- standards
Technology, Radiologic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.