Consulting, IT, Manufacturing and White Paper

Search:

DAY

WEEK

MONTH

YEAR

Select your country:
Sign up | Log in

Consulting

Manufacturing

White Paper

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

FDA Law

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and controls (CMC).

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

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. Biotechnology and Biomanufacturing; Harnessing Research and Development to Further Societal Goals.” bioeconomy.” The first goal under Theme 1—Goal 1.1—is

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

Stay Connected