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Consulting

White Paper

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog

JANUARY 4, 2023

As you may know, there are challenges related to developing potency assay(s), and the Alliance for Regenerative Medicine and the American Society of Gene and Cell Therapy recently published a white paper on a workshop held to discuss these challenges. The workshop is also discussed in Cell & Gene here and here.

Manufacturing

Manufacturing Engineering Clinic Provider

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 Blog

JANUARY 24, 2024

in 5 Years.” As discussed in the new report, producing 25% of all APIs for small molecule drugs within 5 years is an achievable goal: To achieve this goal, this white paper proposes API manufacturers adopt advanced manufacturing technologies provisioned through public incentives.

Supply Chain

Supply Chain Manufacturing Government Provider

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

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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