2023, Appointment, Manufacturing and Medical

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2023

Appointment

Manufacturing

Medical

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

FDA Law

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. As of March 1, 2023, FDA had enrolled four cardiovascular devices in the TAP Pilot.

Manufacturing

Manufacturing Medical Patient-Centered Appointment

A Bold Goal: Reshoring 25% of Small Molecule API to the U.S. in 5 Years – APIIC’s Report to The White House

FDA Law

JANUARY 24, 2024

Fast-forward to March 2023, when The White House OSTP issued a document per Executive Order 14081, titled “ Bold Goals for U.S. That’s a pretty lofty API manufacturing goal, but one that the API Innovation Center (“APIIC”) was charged to take up, consider, and propose some possible solutions. And so in November 2023 in St.

Supply Chain

Supply Chain Manufacturing Government Provider

Primary Care Digest

“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

A Bold Goal: Reshoring 25% of Small Molecule API to the U.S. in 5 Years – APIIC’s Report to The White House

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