Subjects: United States. Food and Drug Administration. / Genre: Technical Report / Copyright: Public domain - Digital Collections - National Library of Medicine Search Results

Start Over Subjects United States. Food and Drug Administration. ✖ Genre Technical Report ✖ Copyright Public domain ✖

1. The "deemed to be a license" provision of the BPCI Act: questions and answers

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

2. 30-Day notices, 135-day premarket approval (PMA) supplements and 75-day humanitarian device exemption (HDE) supplements for manufacturing method or process changes: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, December 16, 2019
Subject(s):: Device Approval -- standards
Equipment and Supplies -- standards
Manufactured Materials -- standards
Device Approval -- legislation & jurisprudence
Time Factors
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

3. 510(k) third party review program: guidance for industry, Food and Drug Administration staff, and third party review organizations

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, March 12, 2020
Subject(s):: Device Approval
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. ANDA submissions--amendments to abbreviated new drug applications under GDUFA

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Subject(s):: Drugs, Generic -- standards
Investigational New Drug Application
Drug Approval
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. ANDA submissions: amendments and requests for final approval to tentatively approved ANDAs

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

6. Acceptance and filing reviews for premarket approval applications (PMAs): guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, December 16, 2019
Subject(s):: Device Approval -- standards
Checklist
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. 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
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8. Acne vulgaris: establishing effectiveness of drugs intended for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Acne Vulgaris -- drug therapy
Drug Evaluation -- standards
Clinical Trials as Topic -- standards
Endpoint Determination
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

9. Adaptive designs for clinical trials of drugs and biologics

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2019
Subject(s):: Adaptive Clinical Trials as Topic -- standards
Investigational New Drug Application
Adaptive Clinical Trials as Topic -- ethics
Biological Products
Drugs, Investigational
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

10. Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017
Subject(s):: Clinical Laboratory Techniques
Device Approval -- standards
Diagnostic Test Approval -- standards
In Vitro Techniques -- standards
Reagent Kits, Diagnostic -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

11. Advancement of emerging technology applications for pharmaceutical innovation and modernization

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Biomedical Technology -- standards
Drug Industry -- standards
Inventions
Quality Assurance, Health Care
Quality Improvement
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

12. Allergic rhinitis: developing drug products for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2018
Subject(s):: Clinical Trials as Topic
Drug Evaluation
Rhinitis, Allergic -- drug therapy
Adrenal Cortex Hormones -- therapeutic use
Adult
Child
Drug Combinations
Research Design
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

13. Alternative procedures for blood and blood components during the COVID-19 public health emergency

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, April 2020
Subject(s):: Blood Donors
Blood Transfusion
Plasma
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

14. Amyotrophic lateral sclerosis: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):: Amyotrophic Lateral Sclerosis -- drug therapy
Clinical Trials as Topic -- standards
Drug Development -- standards
Pharmacokinetics
Research Design -- standards
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

15. Anthrax: developing drugs for prophylaxis of inhalational anthrax

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Anthrax -- drug therapy
Anthrax -- prevention & control
Antibiotic Prophylaxis
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Inhalation Exposure
Adult
Child
Endpoint Determination
Microbial Sensitivity Tests -- standards
Pediatrics
Product Surveillance, Postmarketing -- standards
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

16. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2017
Subject(s):: Anti-Bacterial Agents -- therapeutic use
Bacterial Infections -- drug therapy
Drug Approval
Drug Resistance, Bacterial
Investigational New Drug Application
Clinical Trials as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

17. Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters

Publication:: Washington, D.C. : U.S. Government Accountability Office, January 2017
Subject(s):: Anti-Bacterial Agents -- therapeutic use
Drug Approval
Drug Industry
Drugs, Investigational
Investigational New Drug Application
Drug Resistance, Bacterial
Guidelines as Topic
Humans
United States
United States. Food and Drug Administration.

18. Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 14, 2018
Subject(s):: Clinical Trials as Topic
Consensus
Device Approval
Equipment and Supplies -- standards
Voluntary Programs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

19. Assessing COVID-19-related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):: Clinical Trials as Topic
COVID-19 -- drug therapy
COVID-19 -- prevention & control
Outpatients
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

20. Assessing user fees under the Biosimilar User Fee Amendments of 2017

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

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