Generic Industry Wants US FDA To Advance Research To Eliminate Need For Clinical BE Studies
Executive Summary
Association For Accessible Medicines representatives say animal studies and in-silico trials could reduce the need for BE studies, but OGD director is not sure.
You may also be interested in...
Pre-ANDA Meetings Proving Tough To Get – Nearly Half Of Requests Denied
During first half of fiscal 2018, US FDA only granted 16 of 31 pre-ANDA meeting requests, but said it was to ensure meetings were productive.
Complex Generics: US FDA Still Wants Comparative Clinical Endpoint Studies For Inhaled, Nasal Drugs
Despite in-vitro advances, FDA officials say more work is needed in refining alternative models before agency disbands its weight-of-evidence approach.