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Start Over Subjects Biological Products ✖Remove constraint Subjects: Biological Products Subjects United States. Food and Drug Administration. ✖Remove constraint Subjects: United States. Food and Drug Administration. Publication Year 2017 to 2019 ✖Remove constraint Publication Year: <span class="from" data-blrl-begin="2017">2017</span> to <span class="to" data-blrl-end="2019">2019</span>

1. Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases

Publication:
Silver Spring, MD : Office of Orphan Products Development, Food and Drug Administration, July 2018
Subject(s):
Drug Approval
Orphan Drug Production
Pediatrics
Adolescent
Biological Products
Child
Clinical Trials as Topic
Colitis, Ulcerative -- drug therapy
HIV Infections -- drug therapy
Infant
Prevalence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Pediatric information incorporated into human prescription drug and biological product labeling

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
Subject(s):
Drug Labeling -- standards
Pediatrics
Product Labeling -- standards
Adolescent
Biological Products
Child
Child, Preschool
Infant
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. Considerations in demonstrating interchangeability with a reference product

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
Subject(s):
Biosimilar Pharmaceuticals -- standards
Drug Substitution
Proteins -- therapeutic use
Biological Products
Clinical Trials as Topic
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. Osteoporosis: nonclinical evaluation of drugs intended for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):
Bone Density Conservation Agents -- therapeutic use
Drug Evaluation, Preclinical -- standards
Osteoporosis -- drug therapy
Anabolic Agents
Biological Products
Bone Density
Research Design
Toxicity Tests -- standards
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6. Placebos and blinding in randomized controlled cancer clinical trials for drug and biological products

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):
Double-Blind Method
Neoplasms -- drug therapy
Placebos
Randomized Controlled Trials as Topic -- standards
Single-Blind Method
Antineoplastic Agents
Biological Products
Randomized Controlled Trials as Topic -- ethics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. 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.