Health Industry Washington Watch

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4 results for: food & drug administration developments

Trump Executive Orders seek to encourage reshoring of pharmaceutical manufacturing and research

5/15/2025 8:42:55 PM

Trump Executive Orders seek to encourage reshoring of pharmaceutical manufacturing and research

By Vicki Tankle Sarah Thompson Schick Matthew Loughran

On May 5, the Trump Administration issued a pair of executive orders that could signal big changes for the drug industry and health...

FDA codifies requirements for the medical device De Novo classification process

10/14/2021 1:24:04 PM

FDA codifies requirements for the medical device De Novo classification process

By Andrew Lu

On October 5, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule to establish requirements for the medical device...

FDA clarifies evidence and knowledge requirements in intended use final rule

8/26/2021 12:30:14 PM

FDA clarifies evidence and knowledge requirements in intended use final rule

By Kevin Madagan Sung Park John Kendzior

On August 2, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule amending existing regulations (21 C.F.R. §...

CMS issues proposed rule that would expedite approval of “breakthrough” devices and codify the standards for “reasonable and necessary” determinations

9/8/2020 8:50:44 PM

CMS issues proposed rule that would expedite approval of “breakthrough” devices and codify the standards for “reasonable and necessary” determinations

By Lara Parkin Carrie Gorner

The October 3, 2019 Executive Order 13890 (“EO 13890”), entitled “Executive Order on Protecting and Improving Medicare for our Nation’s...