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1541. Enforcement policy for face masks, barrier face coverings, face shields, surgical 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, September 2021
Subject(s):: COVID-19
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

1542. Interpreting sameness of gene therapy products under the orphan drug regulations

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, September 2021
Subject(s):: Genetic Therapy
Orphan Drug Production -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1543. Development of abbreviated new drug applications during the COVID-19 pandemic: questions and answers

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, September 8, 2021
Subject(s):: COVID-19
Drug Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1544. Questions and answers on biosimilar development and the BPCI Act

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2021
Subject(s):: Biosimilar Pharmaceuticals
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.

1545. Technical specifications for submitting clinical trial data sets for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH)

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, January 2022
Subject(s):: Clinical Trials as Topic
Non-alcoholic Fatty Liver Disease -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1546. Conduct of clinical trials of medical products during the COVID-19 public health emergency: guidance for industry, investigators, and institutional review boards

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, August 30, 2021
Subject(s):: Clinical Trials as Topic
Device Approval
Drug Approval
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1547. Nonmetastatic castration-resistant prostate cancer: considerations for metastasis-free survival endpoint in clinical trials

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2021
Subject(s):: Clinical Trials as Topic
Prostatic Neoplasms, Castration-Resistant
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1548. Development and submission of near infrared analytical procedures

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2021
Subject(s):: Spectroscopy, Near-Infrared -- methods
Spectroscopy, Near-Infrared -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1549. Field alert report submission: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2021
Subject(s):: Drug Approval
Research Design
Research Report
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

1550. Submission of plans for cigarette packages and cigarette advertisements (revised)

Publication:: Silver Spring, MD : Center for Tobacco Products, July 2021
Subject(s):: Advertising
Government Regulation
Product Labeling
Tobacco Products
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

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