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621. Technical specifications for submitting clinical trial data sets for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH)

Publication:

[Silver Spring, MD] : Center for Drug Evaluation and Research, January 2022

Subject(s):

Clinical Trials as Topic
Non-alcoholic Fatty Liver Disease -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

622. Enforcement policy for viral transport media during the coronavirus disease 2019 (COVID19) public health emergency (revised): guidance for commercial manufacturers, clinical laboratories, and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, November 2021

Subject(s):

Culture Media
Specimen Handling
Transportation
Virus Diseases
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

623. Non-clinical and clinical investigation of devices used for the treatment of benign prostatic hyperplasia (BPH): guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, December 27, 2021

Subject(s):

Device Approval
Prostatic Hyperplasia -- therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

624. Enforcement policy for face masks, barrier face coverings, face shields, surgical masks, and respirators during the coronavirus disease (COVID-19) public health emergency (revised): guidance for industry and Food and Drug Administration staff

Publication:

[Silver Spring, MD] : Center for Devices and Radiological Health, September 2021

Subject(s):

COVID-19
Masks
N95 Respirators
Personal Protective Equipment
Respiratory Protective Devices
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

625. Development of abbreviated new drug applications during the COVID-19 pandemic: questions and answers

Publication:

[Silver Spring, MD] : Center for Drug Evaluation and Research, September 8, 2021

Subject(s):

COVID-19
Drug Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

626. Voluntary sodium reduction goals: target mean and upper bound concentrations for sodium in commercially processed, packaged, and prepared foods

Publication:

[Silver Spring, MD] : Center for Food Safety and Applied Nutrition, October 2021

Subject(s):

Food Handling
Food-Processing Industry
Sodium, Dietary
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

627. Nonmetastatic castration-resistant prostate cancer: considerations for metastasis-free survival endpoint in clinical trials

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, August 2021

Subject(s):

Clinical Trials as Topic
Prostatic Neoplasms, Castration-Resistant
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

628. Field alert report submission: questions and answers

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, July 2021

Subject(s):

Drug Approval
Research Design
Research Report
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

629. Unique Device Identification System: form and content of the unique device identifier (UDI) : guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, July 7, 2021

Subject(s):

Equipment and Supplies
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

630. Electronic prescribing of controlled substances among office-based physicians: 2017

Author(s):

Parasrampuria, Sonal, author
Blanco, Martín, author
Barker, Wesley, author

Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, September 2019

Subject(s):

Controlled Substances
Electronic Prescribing -- statistics & numerical data
Practice Patterns, Physicians' -- statistics & numerical data
Prescription Drug Diversion -- prevention & control
Electronic Health Records
Medicare Part D
United States
United States. Department of Health and Human Services