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4711. 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.

4712. Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019
Subject(s):
Compassionate Use Trials -- standards
Cost-Benefit Analysis
Device Approval -- standards
Equipment and Supplies -- classification
Uncertainty
Data Collection
Reagent Kits, Diagnostic
Research Design
Sample Size
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4713. Evaluation of internal standard responses during chromatographic bioanalysis: questions and answers

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):
Chromatography -- standards
Drug Approval
Quality Control
Reference Standards
Calibration
Chemistry Techniques, Analytical
Investigational New Drug Application
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4714. Drugs for treatment of partial onset seizures: full extrapolation of efficacy from adults to pediatric patients 2 years of age and older

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):
Anticonvulsants -- therapeutic use
Clinical Trials as Topic
Drug Development -- standards
Seizures -- drug therapy
Adolescent
Anticonvulsants -- pharmacology
Child
Child, Preschool
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4715. Humanitarian device exemption (HDE) program: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 6, 2019
Subject(s):
Compassionate Use Trials -- standards
Device Approval -- standards
Cost-Benefit Analysis
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4717. Citizen petitions and petitions for stay of action subject to section 505(q) of the Federal Food, Drug, and Cosmetic Act

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):
Drug Approval -- legislation & jurisprudence
Investigational New Drug Application -- legislation & jurisprudence
Public Health -- legislation & jurisprudence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

4718. 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.

4719. Amyotrophic lateral sclerosis: developing drugs for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):
Amyotrophic Lateral Sclerosis -- drug therapy
Clinical Trials as Topic -- standards
Drug Development -- standards
Pharmacokinetics
Research Design -- standards
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4720. Changes to existing medical software policies resulting from section 3060 of the 21st Century Cures Act: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 27, 2019
Subject(s):
Equipment and Supplies -- standards
Software -- legislation & jurisprudence
Electronic Health Records
Healthy Lifestyle
Hospital Information Systems
Mobile Applications -- legislation & jurisprudence
Software -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.
United States.