Subjects: Investigational New Drug Application - Digital Collections - National Library of Medicine Search Results

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NLM Digital Collections

Start Over Subjects Investigational New Drug Application

1. Competitive generic therapies

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

2. 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 Treatment
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

3. Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2020
Subject(s):: Biomarkers
Clinical Trials as Topic
Drug Approval
Drug Development
Drugs, Investigational
Hematologic Neoplasms -- drug therapy
Investigational New Drug Application
Neoplasm, Residual
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4. Determining whether to submit an ANDA or a 505(b)(2) application

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
Subject(s):: Drug Approval
Drugs, Investigational
Investigational New Drug Application
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.

5. Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination

Publication:: Silver Spring, MD : Food and Drug Administration, Oncology Center of Excellence, October 2019
Subject(s):: Device Approval
Drug Approval
Investigational New Drug Application
Medical Oncology
Reagent Kits, Diagnostic -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6. 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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

7. Chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020
Subject(s):: Chemistry, Pharmaceutical
Genetic Therapy
Investigational New Drug Application
Drugs, Investigational
Quality Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

8. Human gene therapy for retinal disorders

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020
Subject(s):: Clinical Trials as Topic
Genetic Therapy
Drug Evaluation, Preclinical
Retinal Diseases -- therapy
Investigational New Drug Application
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

9. Bioavailability studies submitted in NDAs or INDs: general considerations

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):: Biological Availability
Clinical Trials as Topic
Drug Approval
Drug Evaluation
Investigational New Drug Application
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

10. Electronic submission of IND safety reports: technical conformance guide

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, April 2022
Subject(s):: Digital Technology
Drug Approval
Investigational New Drug Application
Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration