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191. Enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during the coronavirus disease 2019 (COVID-19) public health emergency (revised): guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, October 2020
Subject(s):
COVID-19
Monitoring, Physiologic
Remote Sensing Technology
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

192. 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):
Drug Compounding -- methods
Drug Compounding -- standards
Ethanol
Hand Sanitizers
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

193. 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
Drug Compounding -- standards
Ethanol
Hand Sanitizers
Methanol
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

195. Cytomegalovirus in transplantation: developing drugs to treat or prevent disease

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2020
Subject(s):
Cytomegalovirus Infections -- drug therapy
Cytomegalovirus Infections -- prevention & control
Organ Transplantation
Stem Cell Transplantation
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

197. COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, May 2020
Subject(s):
Biological Products
COVID-19 -- drug therapy
Drug Approval
Drug Industry
Drugs, Investigational
Drug Evaluation, Preclinical
Investigational New Drug Application
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

198. Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions 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, May 2020
Subject(s):
Device Approval
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

199. Postmarketing adverse event reporting for medical products and dietary supplements during a pandemic

Publication:
Silver Spring, MD : Office of Counterterrorism and Emerging Threats, May 2020
Subject(s):
Dietary Supplements -- adverse effects
Drug-Related Side Effects and Adverse Reactions
Equipment Design -- adverse effects
Equipment Safety
Product Surveillance, Postmarketing
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

200. Policy for coronavirus disease-2019 tests during the public health emergency (revised): immediately in effect guidance for clinical laboratories, commercial manufacturers, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 11, 2020
Subject(s):
Clinical Laboratory Techniques
COVID-19 Serological Testing
COVID-19 Testing
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.