Change Problems Lead Design Control Deficiency List
This article was originally published in The Gray Sheet
Inadequate design and development plans has emerged as the number one design control infraction since FDA began full enforcement of the quality system requirements in June 1998.
You may also be interested in...
Cilta-cel maintained high response rates in longer-term multiple myeloma data, but ide-cel causes less cytokine release syndrome and severe neurotoxicity – and it has a March decision date at the US FDA.
Our updated graphic tracker of key developments from the leading vaccine candidates.
Pathway open for drug as post-covalent BTK option as Loxo gears up for "risky" Phase III head-to-head study in Q1 2021.