Subjects: Drug Industry and Drug Approval - Digital Collections - National Library of Medicine Search Results

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1. Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):: Communication
Equipment and Supplies -- economics
Insurance, Health, Reimbursement -- economics
Pharmaceutical Preparations -- economics
Truth Disclosure
Costs and Cost Analysis
Device Approval
Drug Approval
Drug Industry
Information Dissemination
Outcome Assessment (Health Care) -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

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 Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters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

3. Risk evaluation and mitigation strategies: modifications and revisions

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

4. COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, May 2020
Subject(s):: Biological Products
COVID-19 -- drug therapy
Drug Approval
Drug Industry
Drugs, Investigational
Drug Evaluation, Preclinical
Investigational New Drug Application
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. Review timelines for applicant responses to complete response letters when a facility assessment is needed during the COVID-19 public health emergency

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, December 2020
Subject(s):: Correspondence as Topic
Drug Approval
Drug Industry
Facility Regulation and Control
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

7. 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.

8. Cover letter attachments for controlled correspondence and ANDA submissions: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
Subject(s):: Correspondence as Topic
Drug Approval
Drug Industry
Drugs, Generic
Government Regulation
United States
United States. Food and Drug Administration

9. Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):: Biological Products
Clinical Trials as Topic
Data Analysis
Decision Making
Drug Approval
Drug Industry
Drug and Narcotic Control
Government Regulation
United States
United States.

10. Benefit-risk assessment for new drug and biological products: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023
Subject(s):: Biological Products
Drug Approval
Drug Industry
Drugs, Investigational
Government Regulation
Pharmaceutical Preparations
Risk Assessment
United States