Starting April 1, 2023, the U.S. Food and Drug Administration (FDA) will begin accepting requests to participate in a new Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot ...
When pharmaceutical companies develop a novel drug for the market, several steps are required to assess and regulate its safety, effectiveness, manufacturability, and reliability. These processes, and ...
In this interview, News-Med talks to Tammy Newbold about the Global Harmonization of Regulatory CMC within Veterinary Medicine. Can you explain what global harmonization of regulatory CMC entails and ...