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Start Over Publication Year 2019 ✖Remove constraint Publication Year: 2019

311. 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.

312. 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.

314. 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.

315. 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.

316. 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.

317. 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.

318. Bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, September 2019
Subject(s):
Bacteriological Techniques
Blood Banks -- standards
Blood Platelets -- microbiology
Blood Preservation -- standards
Platelet Transfusion -- standards
Transfusion Reaction -- prevention & control
Product Labeling -- standards
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

319. Further testing of donations that are reactive on a licensed donor screening test for antibodies to hepatitis C virus

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, October 2019
Subject(s):
Blood -- virology
Blood Banks -- standards
Blood Donors
Hepatitis C -- blood
Hepatitis C -- transmission
Donor Selection
Hepatitis C Antibodies -- blood
Nucleic Acid Amplification Techniques
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

320. Investigational enzyme replacement therapy products: nonclinical assessment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, October 2019
Subject(s):
Drug Evaluation, Preclinical -- standards
Enzyme Replacement Therapy -- standards
Models, Animal
Research Design
Safety
Toxicity Tests -- standards
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.