Subjects: United States. Food and Drug Administration - Digital Collections - National Library of Medicine Search Results

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51. Acute myeloid leukemia: developing drugs and biological products for treatment : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Biological Products
Drug Development -- legislation & jurisprudence
Government Regulation
Leukemia, Myeloid, Acute -- drug therapy
United States
United States. Food and Drug Administration

52. Insanitary conditions at compounding facilities

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
Subject(s):: Drug Compounding
Drug Industry -- standards
Facility Regulation and Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

53. Nonclinical testing of orally inhaled nicotine-containing drug products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2020
Subject(s):: Administration, Inhalation
Tobacco Use Cessation Devices
Toxicity Tests
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

54. Referencing approved drug products in ANDA submissions

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2020
Subject(s):: Drug Approval
Drugs, Generic
Reference Books, Medical
Therapeutic Equivalency
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

55. Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, August 30, 2021
Subject(s):: Clinical Trial Protocols as Topic
Clinical Trials as Topic -- methods
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

56. Notifying CDRH of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act during the COVID-19 public health emergency (revised): guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 2020
Subject(s):: Equipment and Supplies
Manufacturing Industry
Medical Device Legislation
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

57. Qualification process for drug development tools: guidance for industry and FDA staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
Subject(s):: Drug Approval
Drug Development -- methods
Drug Development -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

58. Formal meetings between FDA and ANDA applicants of complex products under GDUFA

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
Subject(s):: Drug Approval
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

59. Regulatory considerations for microneedling products: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 10, 2020
Subject(s):: Medical Device Legislation
Needles -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

60. Enhancing the diversity of clinical trial populations: eligibility criteria, enrollment practices, and trial designs

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
Subject(s):: Biological Variation, Population
Clinical Trial Protocols as Topic
Clinical Trials as Topic
Population Characteristics
Cultural Diversity
Genetic Variation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

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