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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 Dates by Range 2000 and later ✖Remove constraint Dates by Range: 2000 and later

41. Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):
Communication
Equipment and Supplies -- economics
Insurance, Health, Reimbursement -- economics
Pharmaceutical Preparations -- economics
Truth Disclosure
Costs and Cost Analysis
Device Approval
Drug Approval
Drug Industry
Information Dissemination
Outcome Assessment (Health Care) -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

42. Logical observation identifiers names and codes for in vitro diagnostic tests: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, June 15, 2018
Subject(s):
Electronic Health Records
Health Information Interoperability
Logical Observation Identifiers Names and Codes
Reagent Kits, Diagnostic
Device Approval
In Vitro Techniques -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

43. S9 nonclinical evaluation for anticancer pharmaceuticals: questions and answers

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):
Antineoplastic Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical
Antineoplastic Agents -- toxicity
Drug Approval
Drug Contamination
Research Design
Toxicity Tests
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

44. Assessing user fees under the biosimilar user fee amendments of 2017

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):
Biosimilar Pharmaceuticals -- economics
Fees and Charges
Investigational New Drug Application -- economics
Drug Evaluation -- economics
Parenteral Nutrition Solutions -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

46. Revised recommendations for reducing the risk of Zika virus transmission by blood and blood components

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, July 2018
Subject(s):
Blood Component Transfusion
Blood Safety -- standards
Blood Transfusion
Zika Virus Infection -- blood
Zika Virus Infection -- transmission
Blood Donors
Zika Virus Infection -- epidemiology
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

48. 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.

50. Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases

Publication:
Silver Spring, MD : Office of Orphan Products Development, Food and Drug Administration, July 2018
Subject(s):
Drug Approval
Orphan Drug Production
Pediatrics
Adolescent
Biological Products
Child
Clinical Trials as Topic
Colitis, Ulcerative -- drug therapy
HIV Infections -- drug therapy
Infant
Prevalence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.