ANDA Filers Fret: Stability Testing Tweaks Will Delay Approvals

The FDA’s plan to require more stability data for ANDAs is likely to slow approvals unless the agency flexes a little, generic-drug makers say. The FDA should consider three months of stability data instead of six months — at least during initial filing of an ANDA, Jubilant Life Sciences said in initial comments on draft agency guidance. The full six-month data set could be provided later in the review process.
Drug Industry Daily