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3104. Patient-focused drug development: collecting comprehensive and representative input : guidance for industry, Food and Drug Administration staff, and other stakeholders

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2020
Subject(s):
Drug Development
Feedback
Sampling Studies
Patient Reported Outcome Measures
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3107. Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia: developing drugs for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2020
Subject(s):
Drug Development
Healthcare-Associated Pneumonia -- drug therapy
Pneumonia, Bacterial -- drug therapy
Pneumonia, Ventilator-Associated -- drug therapy
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3108. Good manufacturing practice considerations for responding to COVID-19 infection in employees in drug and biological products manufacturing

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, June 2020
Subject(s):
Biological Products
COVID-19 -- prevention & control
Drug Industry
Manufacturing and Industrial Facilities
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3109. 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.

3110. 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.