Peek Behind the FDA Curtain: Crack the Code on OOS Mysteries, one of the top 5 most cited observations by FDA with Binh Nguyen, Sr. Director, Lachman Consultants, and Former FDA #eminencegroupventures #eminencebusinessmedia #ebmgmp4
Did you know that Office of Combination Products (OCP) at FDA was established in 2002 as required by Sec. 204 of the Medical Device User...
What is release by exception? In manufacturing, there are instances where things may not always go as planned. It can be minor or major...
Some diseases are so rare that going through the traditional Phases 1, 2, and 3 studies would be too costly and time consuming and quite...
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