After thinking about our blog post yesterday (here http://www.lachmanconsultants.com/2019/01/the-20-day-window-catch-how-will-it-play-out-and-other-questions/), it now becomes clear why the update to receipts and approvals for the December posting of the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics/ucm375079.htm) left out the number of December receipts. It is because the FDA has not yet decided how to handle application receipts that came in after the shutdown on December 22, 2018.
They don’t know what to report because they have not decided what policy to apply to ANDAs submitted during the shutdown and what the actual submission date will be assigned.
They clearly know how many ANDAs have hit the gateway and when, but if you review the potential decision options (and there may be more that were not articulated) from yesterday’s post, which they will apply to each ANDA, it appears that the final decision will still be a work in progress! Any decisions that might advantage one applicant or disadvantage another might be subject to legal challenge depending on the Agency’s final decision. Good luck to all!
