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1. 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

2. 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

3. Human gene therapy for rare diseases

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020

Subject(s):

Drug Development
Genetic Therapy
Rare Diseases -- therapy
Clinical Trials as Topic
Drug Evaluation, Preclinical
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4. Human gene therapy for hemophilia

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020

Subject(s):

Genetic Therapy
Hemophilia A -- drug therapy
Hemophilia B -- drug therapy
Clinical Trials as Topic
Drug Evaluation, Preclinical
Factor VIII -- therapeutic use
Factor IX -- therapeutic use
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. Long term follow-up after administration of human gene therapy products

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020

Subject(s):

Genetic Therapy -- adverse effects
Product Surveillance, Postmarketing
Drug Evaluation, Preclinical
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6. Nonclinical considerations for mitigating nonhuman primate supply constraints arising from the COVID-19 pandemic

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, February 2022

Subject(s):

Biological Products
Drug Evaluation, Preclinical
Primates
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

7. Nonclinical evaluation of the immunotoxic potential of pharmaceuticals: guidance for industry

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, June 2023

Subject(s):

Drug Evaluation, Preclinical
Drug Industry
Government Regulation
Pharmaceutical Preparations
Toxicity Tests
United States

8. S1B(R1) addendum to S1B testing for carcinogenicity of pharmaceuticals: guidance for industry

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, November 2022

Subject(s):

Carcinogenicity Tests -- standards
Drug Evaluation, Preclinical
Government Regulation
United States
United States. Food and Drug Administration

9. Recurrent herpes labialis: developing drugs for treatment and prevention

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, November 2017

Subject(s):

Antiviral Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical
Drugs, Investigational -- therapeutic use
Herpes Labialis -- drug therapy
Herpes Labialis -- prevention & control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

10. S9 nonclinical evaluation for anticancer pharmaceuticals: questions and answers

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, June 2018

Subject(s):

Antineoplastic Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration