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6361. Policy for testing of alcohol (ethanol) and isopropyl alcohol for methanol, including during the public health emergency (COVID-19)

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, January 2021
Subject(s):: 2-Propanol
Drug Compounding
Ethanol
Methanol
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6362. Protecting participants in bioequivalence studies for abbreviated new drug applications during the COVID-19 public health emergency

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, January 2021
Subject(s):: Drug Approval
Patient Safety
Therapeutic Equivalency
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6363. COVID-19: potency assay considerations for monoclonal antibodies and other therapeutic proteins targeting SARS-CoV-2 infectivity

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, January 2021
Subject(s):: Antibodies, Monoclonal
COVID-19 -- drug therapy
Enzyme-Linked Immunosorbent Assay
SARS-CoV-2
Viral Plaque Assay
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6364. Requests for feedback and meetings for medical device submissions: the Q-Submission Program : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, January 6, 2021
Subject(s):: Device Approval
Formative Feedback
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6365. Safer technologies program for medical devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, January 6, 2021
Subject(s):: Device Approval
Equipment Safety
Voluntary Programs
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6366. Mouse embryo assay for assisted reproduction technology devices: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, January 5, 2021
Subject(s):: Biological Assay
Device Approval
Embryo, Mammalian
Mice
Reproductive Techniques, Assisted
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6367. Consumer Antiseptic Rub Final Rule: questions and answers : small entity compliance guide

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2020
Subject(s):: Hand Sanitizers -- chemistry
Hand Sanitizers -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6368. Effects of the COVID-19 public health emergency on formal meetings and user fee applications for medical devices: questions and answers (revised) : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, June 2020
Subject(s):: Device Approval
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6369. Enforcement policy for the Quality Standards of the Mammography Quality Standards Act during the COVID-19 public health emergency: guidance for mammography facilities, state MQSA contract partners, FDA approved MQSA accreditation bodies, and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, December 2020
Subject(s):: Facility Regulation and Control
Mammography -- standards
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6370. Product labeling for laparoscopic power morcellators: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, December 30, 2020
Subject(s):: Laparoscopy
Morcellation
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

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