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6261. Temporary policy for compounding of certain drugs for hospitalized patients by pharmacy compounders not registered as outsourcing facilities during the COVID-19 public health emergency (revised)

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, Office of Compliance May 21, 2020
Subject(s):: Drug Compounding -- methods
Hospitalization
Outsourced Services
Pharmacies
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6262. Temporary policy for compounding of certain drugs for hospitalized patients by outsourcing facilities during the COVID-19 public health emergency (revised)

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, May 21, 2020
Subject(s):: Drug Compounding -- methods
Hospitalization
Outsourced Services
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6263. Enforcement policy for clinical electronic thermometers during the Coronavirus disease 2019 (COVID-19) public health emergency: guidance for Industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, Office of Product Evaluation and Quality, April 2020
Subject(s):: Thermometers -- supply & distribution
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6264. Enforcement policy for extracorporeal membrane oxygenation and cardiopulmonary bypass devices during the Coronavirus disease 2019 (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, Office of Product Evaluation and Quality April 2020
Subject(s):: Cardiopulmonary Bypass -- instrumentation
Extracorporeal Membrane Oxygenation -- instrumentation
COVID-19 -- therapy
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6265. Cancer clinical trial eligibility criteria: patients with HIV, hepatitis B Virus, or hepatitis C Virus Infections

Publication:: [Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):: Clinical Trials as Topic
Hepatitis B
Hepatitis C
HIV
Neoplasms
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6266. Temporary policy for preparation of certain alcohol-based hand sanitizer products during the public health emergency (COVID-19)

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, February 10, 2021
Subject(s):: Ethanol
Hand Sanitizers
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6267. Temporary policy for manufacture of alcohol for incorporation into alcohol-based hand sanitizer products during the public health emergency (COVID-19)

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, February 10, 2021
Subject(s):: Ethanol
Hand Sanitizers
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6268. Policy for temporary compounding of certain alcohol-based hand sanitizer products during the public health emergency: immediately in effect guidance for industry

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, February 10, 2021
Subject(s):: Drug Compounding -- methods
Ethanol
Hand Sanitizers
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6269. Conventional Foley catheters--performance criteria for safety and performance based pathway: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, August 14, 2020
Subject(s):: Equipment Design
Equipment Safety
Urinary Catheterization
Urinary Catheters -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6270. Cutaneous electrodes for recording purposes--performance criteria for safety and performance based pathway: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, August 14, 2020
Subject(s):: Electrodes
Equipment Design
Equipment Safety
Electrocardiography
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

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