FDA Officials Say Potency Problems Main Reason for NTI Drug Recalls
This article was originally published in The Gold Sheet
FDA officials said that use of quality by design as well as “equivalence by design” will help drug manufacturers develop better generic substitutions of narrow therapeutic index (NTI) drugs to address the high rate of recalls associated with these products due to potency problems.
You may also be interested in...
FDA’s challenges in creating a more specific definition of narrow therapeutic index drugs were on clear display at the most recent advisory committee meeting on the topic: There’s wide support for the project, but equally broad concern that it needs to be more carefully tailored.
Its ‘virus chasing’ habits has given Inovio a bad reputation. But with backing from CEPI and Bill Gates, it has a chance to prove the doubters wrong.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.