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1. E11(R1) addendum: clinical investigation of medicinal products in the pediatric population

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):
Clinical Trials as Topic -- ethics
Drug Compounding -- standards
Pediatrics
Pharmaceutical Preparations
Child
Excipients
Infant
Infant, Newborn
International Cooperation
Models, Theoretical
Pharmaceutical Preparations -- administration & dosage
Taste
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Anthrax: developing drugs for prophylaxis of inhalational anthrax

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):
Anthrax -- drug therapy
Anthrax -- prevention & control
Antibiotic Prophylaxis
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Inhalation Exposure
Adult
Child
Endpoint Determination
Microbial Sensitivity Tests -- standards
Pediatrics
Product Surveillance, Postmarketing -- standards
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. 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.

6. Pediatric trauma centers: availability, outcomes, and federal support related to pediatric trauma care : report to Congressional requesters

Publication:
Washington, D.C. : U.S. Government Accountability Office, March 2017
Subject(s):
Emergency Medical Services -- statistics & numerical data
Health Services Accessibility
Outcome Assessment (Health Care)
Pediatrics
Trauma Centers
Wounds and Injuries -- therapy
Child
Financing, Government
Hospital Mortality
Humans
United States
United States. Department of Health and Human Services.
United States. Health Resources and Services Administration.
National Institutes of Health (U.S.)

8. Cancer clinical trial eligibility criteria: minimum age considerations for inclusion of pediatric patients : guidance for industry and IRBs

Publication:
Silver Spring, MD : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):
Clinical Trials as Topic
Eligibility Determination
Neoplasms
Pediatrics
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

12. Severely debilitating or life-threatening hematologic disorders: nonclinical development of pharmaceuticals

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
Subject(s):
Drug Evaluation, Preclinical -- standards
Hematologic Diseases -- drug therapy
Animals
Carcinogenicity Tests
Cytotoxicity Tests, Immunologic
Drug Therapy, Combination
Drug-Related Side Effects and Adverse Reactions
Immunologic Tests
Mutagenicity Tests
Pediatrics
Pharmacokinetics
Photochemistry
Safety
Toxicity Tests
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

13. 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.

14. 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.

15. Oncology pharmaceuticals: reproductive toxicity testing and labeling recommendations

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
Subject(s):
Antineoplastic Agents -- adverse effects
Mutagenicity Tests -- standards
Neoplasms -- drug therapy
Reproduction -- drug effects
Teratogens
Toxicity Tests -- standards
Contraception
Drug-Related Side Effects and Adverse Reactions
Fertility
Geriatrics
Pediatrics
Postmenopause
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.