QUOTED. 21 November 2019. Ricki Chase.
Device manufacturers often fall down when conducting process validation activities because they fail to continually monitor their processes, consultant and former FDA investigations branch director Ricki Chase says. See her comments here.
You may also be interested in...
Process Validation Can Be Problematic For Device-Makers. Here’s Why – And What Companies Can Do About It
Medical device manufacturers often stumble when conducting process validation activities. In this Q&A, former US FDA investigations branch director Ricki Chase explains what those hurdles are and offers tips to firms to make sure they’re on the road to compliance.
US FDA usually recommends using overall survival for pancreatic cancer drugs, but AstraZeneca choose progression-free survival; now ODAC will weigh in on whether the PARP inhibitor olaparib demonstrated a clinically meaningful impact. The firm cites enrollment and design challenges in the gBRCAm population as reasons for using PFS.