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Start Over Formats Text ✖Remove constraint Formats: Text Subjects Humans ✖Remove constraint Subjects: Humans Subjects United States. Food and Drug Administration. ✖Remove constraint Subjects: United States. Food and Drug Administration. Genre Technical Report ✖Remove constraint Genre: Technical Report Copyright Public domain ✖Remove constraint Copyright: Public domain Dates by Range 2000 and later ✖Remove constraint Dates by Range: 2000 and later

1. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. Assessing user fees under the Prescription Drug User Fee Amendments of 2017

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):
Fees and Charges
Investigational New Drug Application -- economics
Prescription Drugs -- economics
Biological Products -- economics
Orphan Drug Production -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

15. 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.

16. BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):
Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Urinary Bladder Neoplasms -- drug therapy
Biological Products -- therapeutic use
Chemistry, Pharmaceutical
Mycobacterium bovis
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

17. Bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, September 2019
Subject(s):
Bacteriological Techniques
Blood Banks -- standards
Blood Platelets -- microbiology
Blood Preservation -- standards
Platelet Transfusion -- standards
Transfusion Reaction -- prevention & control
Product Labeling -- standards
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

19. Best practices for communication between IND sponsors and FDA during drug development: guidance for industry and review staff : good review practice

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Subject(s):
Communication
Drug Industry
Investigational New Drug Application
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

20. Bioanalytical method validation

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):
Drug Evaluation, Preclinical -- standards
Reproducibility of Results
Research Design -- standards
Validation Studies as Topic
Biomarkers
Documentation
Dried Blood Spot Testing -- standards
Investigational New Drug Application
Quality Control
Reagent Kits, Diagnostic -- standards
Sensitivity and Specificity
Specimen Handling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.