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United States: Status of FDA COVID-19-related guidance documents in the 'post-COVID' era

On March 13, 2023, FDA issued a notice regarding guidance documents related to the COVID-19 pandemic, including which of the guidance documents will… ....

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The End of an Era: FDA Announces Disposition Plans for COVID-19 Related Guidance Documents | Wiley Rein LLP

The COVID-19 pandemic presented the U.S. Food and Drug Administration (FDA or Agency) with a monumental task of shifting its operations and the way it approached the regulation of. ....

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The Long (Un)Winding Road: FDA Maps Out How the End of the Public Health Emergency Will Impact its COVID-19 Policies | Goodwin

Since the beginning of the COVID-19 pandemic, the US Food and Drug Administration (FDA or the Agency) has issued more than 80 guidance documents describing flexibilities that would be. ....

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Development of Biosimilar and Interchangeable Biological Products During the COVID-19 Pandemic: What the ANDA Guidance Left Unsaid | King & Spalding

Development of Biosimilar and Interchangeable Biological Products During the COVID-19 Pandemic: What the ANDA Guidance Left Unsaid | King & Spalding
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FDA Issues New Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities | Alston & Bird

FDA Issues New Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities | Alston & Bird
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