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Start Over Languages English ✖Remove constraint Languages: English Publication Year 2020 ✖Remove constraint Publication Year: <span class="single" data-blrl-single="2020">2020</span>

121. Enforcement policy for face masks and respirators during the coronavirus disease (COVID-19) public health emergency (revised): guidance for industry and food and drug administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 2020
Subject(s):
COVID-19 -- prevention & control
Masks
N95 Respirators
Personal Protective Equipment
Respiratory Protective Devices
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

124. Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, October 2020
Subject(s):
Drug Industry
Drug and Narcotic Control
Pharmaceutical Preparations
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

125. Necessary automated external defibrillator accessories: policy regarding compliance date : guidance for industry, stakeholders, health care professionals, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, October 28, 2020
Subject(s):
Defibrillators
Device Approval
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

126. Certificates of confidentiality: guidance for sponsors, sponsor-investigators, researchers, industry, and food and drug administration staff

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research September 2020
Subject(s):
Biomedical Research
Confidentiality
Privacy
Research Subjects
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

128. Assessing COVID-19-related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):
Clinical Trials as Topic
COVID-19 -- drug therapy
COVID-19 -- prevention & control
Outpatients
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

130. Importation of certain FDA approved human prescription drugs, including biological products, and combination products under section 801(d)(1)(b) of the Federal Food, Drug, and Cosmetic Act

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):
Biological Products
Drug Labeling
Prescription Drugs
Counterfeit Drugs
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.