NLM Digital Collections

Search

Start Over Collections Health Policy and Services Research ✖Remove constraint Collections: Health Policy and Services Research Subjects Drug-Related Side Effects and Adverse Reactions ✖Remove constraint Subjects: Drug-Related Side Effects and Adverse Reactions

13. 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.

14. REMS: FDA's application of statutory factors in determining when a REMS is necessary

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2019
Subject(s):
Drug Evaluation -- legislation & jurisprudence
Risk Evaluation and Mitigation -- legislation & jurisprudence
Cost of Illness
Drug-Related Side Effects and Adverse Reactions
Health Services Accessibility
Prescription Drugs -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

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.

16. Testing of glycerin, propylene glycol, maltitol solution, hydrogenated starch hydrolysate, sorbitol solution, and other high-risk drug components for diethylene glycol and ethylene glycol: guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
Subject(s):
Drug Contamination
Drug Industry
Drug-Related Side Effects and Adverse Reactions
Ethylene Glycols
Glycerol
Government Regulation
Propylene Glycol
Sorbitol
United States