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Consulting

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

FDA Law

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. In case you do not have time to watch the town hall , we provided a summary of select topics that are discussed below.

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

JANUARY 24, 2024

One component of the OSTP report is “Biotechnology and Biomanufacturing R&D to Further Supply Chain Resilience,” and it includes nine goals in three themes “intended to provide a broad vision to build supply chain resilience for the U.S. bioeconomy.”

Supply Chain

Supply Chain Manufacturing Government Provider

Primary Care Digest

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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