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6221. 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.

6222. 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.

6223. 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.

6224. 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.

6225. 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.

6226. 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.

6227. Compliance policy for the quantity of bioavailability and bioequivalence samples retained under 21 CFR 320.38(c)

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, August 2020
Subject(s):: Biological Availability
Therapeutic Equivalency
Biopharmaceutics
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6228. Civil money penalties relating to the ClinicalTrials.gov data bank: guidance for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff

Publication:: Silver Spring, MD : United States Food and Drug Administration, Office of Good Clinical Practice. August 2020
Subject(s):: Clinical Trials as Topic
Databases as Topic
Data Management -- legislation & jurisprudence
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6229. Limited population pathway for antibacterial and antifungal drugs

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, August 2020
Subject(s):: Anti-Bacterial Agents
Antifungal Agents
Legislation, Drug
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6230. Alternative procedures for blood and blood components during the COVID-19 public health emergency

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, April 2020
Subject(s):: Blood Donors
Blood Transfusion
Plasma
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

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