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1421. Formal dispute resolution: sponsor appeals above the division level : guidance for industry and review staff : good review practice

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Dissent and Disputes
Investigational New Drug Application
Negotiating
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

1423. Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Antiviral Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Hepatitis C, Chronic -- drug therapy
Antiviral Agents -- pharmacokinetics
Drugs, Investigational -- pharmacokinetics
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

1424. Recurrent herpes labialis: developing drugs for treatment and prevention

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Antiviral Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical
Drugs, Investigational -- therapeutic use
Herpes Labialis -- drug therapy
Herpes Labialis -- prevention & control
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

1425. Evaluating drug effects on the ability to operate a motor vehicle

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Automobile Driving
Driving Under the Influence
Drug Evaluation -- standards
Psychotropic Drugs -- adverse effects
Evaluation Studies as Topic
Reaction Time -- drug effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

1426. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, December 2017
Subject(s):
Autografts -- standards
Biological Products -- standards
Biological Products -- therapeutic use
Tissue Transplantation -- standards
Transplantation, Autologous
Transplantation, Homologous
Transplants -- standards
Prostheses and Implants -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

1427. Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, November 2017
Subject(s):
Autografts -- standards
Biological Products -- standards
Biological Products -- therapeutic use
Tissue Transplantation
Transplantation, Autologous
Transplantation, Homologous
Transplants -- standards
Prostheses and Implants -- standards
Surgical Procedures, Operative
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

1428. Unique device identification: direct marking of devices : guidance for Industry and Food and Drug administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, November 17, 2017
Subject(s):
Equipment and Supplies -- standards
Equipment Reuse -- standards
Product Labeling -- standards
Device Approval -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

1429. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Abuse-Deterrent Formulations -- standards
Analgesics, Opioid -- administration & dosage
Drugs, Generic
Investigational New Drug Application
Administration, Oral
Administration, Inhalation
Clinical Trials as Topic
Drug Evaluation, Preclinical
Injections
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

1430. Pediatric information for x-ray imaging device premarket notifications: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, November 28, 2017
Subject(s):
Equipment Safety -- standards
Product Labeling -- standards
Radiation Dosage
Radiation Exposure -- adverse effects
Radiation Exposure -- standards
Radiography -- adverse effects
Radiography -- instrumentation
Adolescent
Child
Child, Preschool
Contraindications
Fluoroscopy -- adverse effects
Fluoroscopy -- instrumentation
Infant
Infant, Newborn
Radiation, Ionizing
Tomography Scanners, X-Ray Computed -- standards
Tomography, X-Ray Computed -- adverse effects
Young Adult
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.