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Start Over Subjects Drug Labeling ✖Remove constraint Subjects: Drug Labeling

21. Oncology therapeutic radiopharmaceuticals: nonclinical studies and labeling recommendations

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):
Drug Evaluation, Preclinical -- standards
Neoplasms -- drug therapy
Radiopharmaceuticals -- pharmacology
Toxicity Tests
Carcinogenicity Tests
Drug Labeling
Lactation -- drug effects
Pharmacokinetics
Radiation Dosage
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

22. Wholesale distributor verification requirement for saleable returned drug product: compliance policy

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):
Commerce -- legislation & jurisprudence
Legislation, Drug
Pharmaceutical Preparations -- standards
Drug Labeling
Drug Packaging
Guideline Adherence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

23. Human prescription drug and biological products: labeling for dosing based on weight or body surface area for ready-to-use containers : “dose banding” : guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, October 2023
Subject(s):
Biological Products -- administration & dosage
Drug Dosage Calculations
Drug Industry
Drug Labeling
Drug Packaging
Government Regulation
Injections -- standards
Prescription Drugs -- administration & dosage
Product Labeling
Product Packaging
United States