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4691. 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.

4692. 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.

4693. FDA deems certain tobacco products subject to FDA authority, sales and distribution restrictions, and health warning requirements for packages and advertisements: (revised)

Publication:
Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, March 2019
Subject(s):
Commerce -- legislation & jurisprudence
Product Labeling -- legislation & jurisprudence
Tobacco Products -- legislation & jurisprudence
Tobacco Products -- supply & distribution
Advertising -- legislation & jurisprudence
Tobacco Products -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

4694. Extension of certain tobacco product compliance deadlines related to the final deeming rule: (revised)

Publication:
Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, March 2019
Subject(s):
Product Labeling -- legislation & jurisprudence
Tobacco Products -- legislation & jurisprudence
Guideline Adherence
Tobacco Products -- adverse effects
Tobacco Products -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

4695. Interpretation of and compliance policy for certain label requirement: applicability of certain Federal Food, Drug, and Cosmetic Act requirements to vape shops

Publication:
Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, March 2019
Subject(s):
Product Labeling -- legislation & jurisprudence
Vaping -- legislation & jurisprudence
Commerce -- legislation & jurisprudence
Guideline Adherence
Product Labeling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

4696. Premarket tobacco product applications for electronic nicotine delivery systems

Publication:
Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, June 2019
Subject(s):
Device Approval -- legislation & jurisprudence
Electronic Nicotine Delivery Systems -- standards
Clinical Trials as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4697. Marketing clearance of diagnostic ultrasound systems and transducers: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, June 27, 2019
Subject(s):
Device Approval
Transducers
Ultrasonography -- instrumentation
Equipment Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4699. Compliance policy for certain compounding of oral oxitriptan (5-HTP) drug products for patients with tetrahydrobiopterin (BH4) deficiency: immediately in effect guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 2019
Subject(s):
Drug Compounding -- standards
5-Hydroxytryptophan -- therapeutic use
Phenylketonurias -- drug therapy
Guideline Adherence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

4700. 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.