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Guidance Documents Pharmaceutical Industry Food and Drug Administration (FDA)

Epstein Becker & Green

Unpacking Averages: Analyzing FDA’s Performance in Finalizing Guidance Documents

FDA’s January 3, 2024, Federal Register notice soliciting comments on the agency’s plan to implement best practices for guidance development got me thinking.  What do the data show regarding FDA’s performance in moving...more

Foley Hoag LLP

FDA Issues New Guidance to Developers of COVID-19 Drugs and Biological

Foley Hoag LLP on

On May 11, the U.S. Food and Drug Administration (FDA) released two guidance documents to provide recommendations for sponsors “to accelerate development” of drugs and biologics designed to prevent or treat COVID-19. ...more

Snell & Wilmer

Adapting Clinical Research During the COVID-19 Pandemic

Snell & Wilmer on

Many sectors of the economy have ground to a halt in the effort to curtail the COVID-19 pandemic (the “Pandemic”), and the clinical research industry is not immune to the effects of these business shutdowns. While the...more

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