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31. BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):
Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Urinary Bladder Neoplasms -- drug therapy
Biological Products -- therapeutic use
Chemistry, Pharmaceutical
Mycobacterium bovis
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

32. Bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, September 2019
Subject(s):
Bacteriological Techniques
Blood Banks -- standards
Blood Platelets -- microbiology
Blood Preservation -- standards
Platelet Transfusion -- standards
Transfusion Reaction -- prevention & control
Product Labeling -- standards
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

34. Basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory medical equipment: standards specific information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020
Subject(s):
Accreditation
Electricity
Equipment Safety
Equipment and Supplies
Mechanical Tests
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

35. Best practices for communication between IND sponsors and FDA during drug development: guidance for industry and review staff : good review practice

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Subject(s):
Communication
Drug Industry
Investigational New Drug Application
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

36. Bioanalytical method validation

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):
Drug Evaluation, Preclinical -- standards
Reproducibility of Results
Research Design -- standards
Validation Studies as Topic
Biomarkers
Documentation
Dried Blood Spot Testing -- standards
Investigational New Drug Application
Quality Control
Reagent Kits, Diagnostic -- standards
Sensitivity and Specificity
Specimen Handling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

37. Biocompatibility testing of medical devices: standards specific information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020
Subject(s):
Accreditation
Equipment and Supplies
Materials Testing -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

38. Biodefense: federal efforts to develop biological threat awareness : report to Congressional requesters

Publication:
Washington, D.C. : U.S. Government Accountability Office, October 2017
Subject(s):
Bioterrorism -- prevention & control
Civil Defense
Awareness
Biological Warfare
Data Collection
Information Dissemination
Public Health
Research
Humans
United States
United States. Department of Agriculture.
United States. Department of Defense.
United States. Department of Health and Human Services.
United States. Department of Homeland Security.
United States. Environmental Protection Agency.