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Presented by Gilead Sciences, Inc.
With Emily Martin and Dan Goldberg
On Tap Michigan lawmakers want Biden to send extra vaccine doses to the hard-hit state. The Congressional Budget Office takes a deep dive on pharmaceutical R&D.
Letter: The choice for public service standard.net - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from standard.net Daily Mail and Mail on Sunday newspapers.
Center for Drug Evaluation and Research
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA is issuing this guidance to provide information pertaining to review timelines that FDA will use during the COVID-19 public health emergency for the following applicant responses to complete response (CR) letters when a facility assessment is necessary before FDA can take action on a marketing application:
Amendments to original and supplemental abbreviated new drug applications (ANDAs) submitted to FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).