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

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1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. Assessing user fees under the prescription drug user fee amendments of 2017

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

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