A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
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