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991. CMC postapproval manufacturing changes for specified biological products to be documented in annual reports

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2021
Subject(s):: Annual Reports as Topic
Biological Products -- standards
Biological Products -- supply & distribution
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

992. Policy for coronavirus disease-2019 tests during the public health emergency (revised): guidance for developers and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 15, 2021
Subject(s):: COVID-19 Serological Testing -- standards
COVID-19 Testing -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

993. 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

994. 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

995. 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

996. 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

997. 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

998. 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

999. 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

1000. 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

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