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Start Over Collections Health Policy and Services Research ✖Remove constraint Collections: Health Policy and Services Research Subjects Humans ✖Remove constraint Subjects: Humans Subjects Drug Approval ✖Remove constraint Subjects: Drug Approval Genre Technical Report ✖Remove constraint Genre: Technical Report Copyright Public domain ✖Remove constraint Copyright: Public domain

31. Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 1, 2019
Subject(s):
Anti-Infective Agents
Device Approval
Drug Approval
Drug Development
Microbial Sensitivity Tests
Drug Industry
Biotechnology
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

33. Evaluation of devices used with regenerative medicine advanced therapies

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, February 2019
Subject(s):
Device Approval
Equipment and Supplies -- classification
Regenerative Medicine -- classification
Regenerative Medicine -- instrumentation
Biological Products -- classification
Cell- and Tissue-Based Therapy -- classification
Drug Approval
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

34. 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.)

35. Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, January 2020
Subject(s):
Biomarkers
Clinical Trials as Topic
Drug Approval
Drug Development
Drugs, Investigational
Hematologic Neoplasms -- drug therapy
Investigational New Drug Application
Neoplasm, Residual
Endpoint Determination
Leukemia, Lymphocytic, Chronic, B-Cell -- drug therapy
Leukemia, Myelogenous, Chronic, BCR-ABL Positive -- drug therapy
Leukemia, Myeloid, Acute -- drug therapy
Leukemia, Promyelocytic, Acute -- drug therapy
Multiple Myeloma -- drug therapy
Patient Selection
Precursor Cell Lymphoblastic Leukemia-Lymphoma -- drug therapy
Prognosis
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

37. Maximal usage trials for topically applied active ingredients being considered for inclusion in an over-the -counter monograph: study elements and considerations

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
Subject(s):
Administration, Topical
Drug Approval
Nonprescription Drugs
Absorption, Physiological
Clinical Trials as Topic
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

39. Evaluation of internal standard responses during chromatographic bioanalysis: questions and answers

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):
Chromatography -- standards
Drug Approval
Quality Control
Reference Standards
Calibration
Chemistry Techniques, Analytical
Investigational New Drug Application
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

40. Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination

Publication:
Silver Spring, MD : Food and Drug Administration, Oncology Center of Excellence, October 2019
Subject(s):
Clinical Trials as Topic
Device Approval
Drug Approval
Investigational New Drug Application
Medical Oncology
Reagent Kits, Diagnostic -- standards
Drugs, Investigational
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.