FDA offers new guidance to help generic drug developers get to market more quickly
The FDA on Wednesday released a trio of new guidance documents under its Drug Competition Action plan to help the generic drug industry with a more efficient and transparent generic drug review process.
One of the two final guidances released deals with how the agency issues and uses information requests (IRs) and discipline review letters (DRLs) during the assessment of an original generic drug application, also known as an abbreviated new drug application or ANDA.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 144,600+ biopharma pros reading Endpoints daily — and it's free.