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Start Over Subjects United States. Department of Health and Human Services. ✖Remove constraint Subjects: United States. Department of Health and Human Services. Dates by Range 2000 and later ✖Remove constraint Dates by Range: 2000 and later

401. 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.

402. 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.

406. 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.

408. Osteoporosis: nonclinical evaluation of drugs intended for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):
Bone Density Conservation Agents -- therapeutic use
Drug Evaluation, Preclinical -- standards
Osteoporosis -- drug therapy
Anabolic Agents
Biological Products
Bone Density
Research Design
Toxicity Tests -- standards
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

409. Placebos and blinding in randomized controlled cancer clinical trials for drug and biological products

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):
Double-Blind Method
Neoplasms -- drug therapy
Placebos
Randomized Controlled Trials as Topic -- standards
Single-Blind Method
Antineoplastic Agents
Biological Products
Randomized Controlled Trials as Topic -- ethics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

410. Factors to consider when making benefit-risk determinations in medical device premarket approval and de novo classifications: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019
Subject(s):
Cost-Benefit Analysis
Device Approval
Equipment and Supplies -- classification
Equipment Safety -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.