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- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
- Subject(s):
- Drug Approval
Drugs, Investigational
Investigational New Drug Application
Drug Labeling
Therapeutic Equivalency
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
- Subject(s):
- Administration, Topical
Drug Approval
Nonprescription Drugs
Absorption, Physiological
Clinical Trials as Topic
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, June 2019
- Subject(s):
- Epidermolysis Bullosa -- drug therapy
Skin Manifestations
Clinical Trials as Topic
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
