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27791. Product labeling for certain ultrasonic surgical aspirator devices: guidance for Industry and Food and Drug Administration staff

Publication:: [Silver Spring, Maryland] : Center for Devices and Radiological Health, October 30, 2017
Subject(s):: Product Labeling -- standards
Ultrasonic Surgical Procedures -- instrumentation
Ultrasonic Surgical Procedures -- standards
Equipment Safety -- standards
Leiomyoma -- surgery
Suction -- instrumentation
Suction -- standards
Surgical Equipment -- adverse effects
Ultrasonic Surgical Procedures -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

27792. Manufacturers sharing patient-specific information from medical devices with patients upon request: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, Maryland] : Center for Devices and Radiological Health, October 30, 2017
Subject(s):: Access to Information
Equipment and Supplies -- standards
Health Records, Personal
Information Dissemination
Patient-Centered Care
Health Policy
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

27793. 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.

27794. Recommended statement for over-the-counter aspirin-containing drug products labeled with cardiovascular related imagery

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):: Aspirin
Drug Labeling
Drug Packaging
Nonprescription Drugs
Cardiovascular System
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

27795. 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.

27796. 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.

27797. 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.

27798. 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.

27799. 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.

27800. 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.