Dates by Range: 2000 and later - Digital Collections - National Library of Medicine Search Results

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4541. 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

4542. Manufacture of blood components using a pathogen reduction device in blood establishments: questions and answers

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, November 2021
Subject(s):: Blood Banks
Blood Component Transfusion -- standards
Blood Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4543. Surgical staplers and staples for internal use: labeling recommendations : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, October 8, 2021
Subject(s):: Product Labeling
Surgical Staplers
Sutures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4544. Reporting amount of listed drugs and biological products technical conformance guide

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2021
Subject(s):: Biological Products
Drug Industry
Drug Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4545. 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

4546. 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

4547. Interpreting sameness of gene therapy products under the orphan drug regulations

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, September 2021
Subject(s):: Genetic Therapy
Orphan Drug Production -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4548. 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

4549. Questions and answers on biosimilar development and the BPCI Act

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2021
Subject(s):: Biosimilar Pharmaceuticals
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.

4550. 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

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