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Start Over Subjects United States. Department of Health and Human Services. ✖Remove constraint Subjects: United States. Department of Health and Human Services. Genre Guideline ✖Remove constraint Genre: Guideline Dates by Range 2000 and later ✖Remove constraint Dates by Range: 2000 and later

111. Use of electronic health record data in clinical investigations

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Subject(s):
Clinical Trials as Topic
Electronic Health Records -- utilization
Health Information Interoperability
Forms and Records Control
Informed Consent
Reproducibility of Results
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

112. Use of public human genetic variant databases to support clinical validity for genetic and genomic-based in vitro diagnostics: guidance for stakeholders and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, April 13, 2018
Subject(s):
Databases, Genetic
Reagent Kits, Diagnostic -- standards
Reproducibility of Results
Access to Information
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

113. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, August 31, 2017
Subject(s):
Equipment and Supplies
Equipment Safety
Evidence-Based Medicine
Product Surveillance, Postmarketing
Data Collection
Data Interpretation, Statistical
Decision Making
Device Approval
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

114. Use of serological tests to reduce the risk of transmission of Trypanosoma cruzi infection in blood and blood components

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, December 2017
Subject(s):
Blood Donors
Chagas Disease -- blood
Chagas Disease -- transmission
Disease Transmission, Infectious -- prevention & control
Donor Selection
Serologic Tests
Trypanosoma cruzi
Chagas Disease -- prevention & control
Risk Management
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

115. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Subject(s):
Biological Availability
Drugs, Investigational -- pharmacokinetics
Investigational New Drug Application
Therapeutic Equivalency
Administration, Oral
Biopharmaceutics -- classification
Drugs, Investigational -- administration & dosage
Excipients
Permeability
Prodrugs
Solubility
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.