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Start Over Collections Health Policy and Services Research ✖Remove constraint Collections: Health Policy and Services Research Subjects United States. Department of Health and Human Services. ✖Remove constraint Subjects: United States. Department of Health and Human Services.

391. 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.

392. 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.

393. 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.

394. 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.

396. 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.

397. 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.

399. Live case presentations during investigational device exemption (IDE) clinical trials: guidance for institutional review boards, industry, clinical investigators, and Food and Drug administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, July 11, 2019
Subject(s):
Clinical Trials as Topic
Device Approval
Data Collection
Ethics Committees, Research
Informed Consent
Single-Case Studies as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

400. Metal expandable biliary stents: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration Staff

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, July 27, 2019
Subject(s):
Bile Ducts
Device Approval -- standards
Self Expandable Metallic Stents -- standards
Biocompatible Materials -- standards
Materials Testing -- standards
Product Labeling -- standards
Product Packaging -- standards
Sterilization -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.