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2. Slowly progressive, low-prevalence rare diseases with substrate deposition that result from single enzyme defects: providing evidence of effectiveness for replacement or corrective therapies

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
Subject(s):
Drug Development -- standards
Drugs, Investigational
Rare Diseases -- drug therapy
Metabolism, Inborn Errors -- drug therapy
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Expansion cohorts: use in first-in-human clinical trials to expedite development of oncology drugs and biologics

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2022
Subject(s):
Antineoplastic Agents
Biological Products
Clinical Trials as Topic
Drug Development -- legislation & jurisprudence
Drug Development -- standards
Medical Oncology
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4. Pediatric HIV infection: drug product development for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
Subject(s):
Drug Development -- standards
HIV Infections -- drug therapy
Pediatrics
Adolescent
Anti-Retroviral Agents -- therapeutic use
Child
Clinical Trials as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. Delayed graft function in kidney transplantation: developing drugs for prevention

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2019
Subject(s):
Delayed Graft Function -- drug therapy
Drug Development -- standards
Kidney Transplantation
Clinical Trials as Topic
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6. Drugs for treatment of partial onset seizures: full extrapolation of efficacy from adults to pediatric patients 2 years of age and older

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):
Anticonvulsants -- therapeutic use
Clinical Trials as Topic
Drug Development -- standards
Seizures -- drug therapy
Adolescent
Anticonvulsants -- pharmacology
Child
Child, Preschool
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. 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.

8. Smallpox (variola virus) infection: developing drugs for treatment or prevention

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2019
Subject(s):
Clinical Trials as Topic
Drug Development -- standards
Smallpox -- drug therapy
Smallpox -- prevention & control
Antiviral Agents -- pharmacology
Antiviral Agents -- therapeutic use
Drug Evaluation, Preclinical
Emergencies
Investigational New Drug Application
Models, Animal
Orthopoxvirus
Public Health
Research Design
Safety
Toxicity Tests
Variola virus
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

9. Considerations for the development of dried plasma products intended for transfusion

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, December 2019
Subject(s):
Blood Transfusion -- standards
Device Approval
Drug Approval
Drug Development -- standards
Plasma
Plasma -- microbiology
Product Packaging
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.