FDA approved and received data published in fy2016

Source: on October 11, 2016, the FDA Office of generic drugs (OGD) released approval and acceptance data and some other indicators for the whole fiscal year 2016 In September, 51 andas were approved by OGD, with a total approval of 651 in fiscal 2016, with an average of 54.25 per month This is at least the year with the highest approval volume in the past 8 years (maybe longer), and the year with the highest approval volume of gdufa phase I (the previous highest is 492 in fy2015 and 517 in fy2012 before gdufa) This is good news! The bad news is that in fiscal 2016 OGD received 853 andas (71 on average per month), which exceeded the approval by 202 Although there are 184 provisional approvals in fy16, there are still some approval shortages on the balance sheet of OGD It's surprising that 60 andas were submitted in September, because we had previously predicted that (with the new review indicator entering fy17 taking the first action on 90% of andas within 10 months), enterprises might wait until after October 1 to submit applications to take advantage of the potential reduction of the review time by 5 months In addition to the five-month time advantage, anda fees will fall by about $6000 in fiscal 2017, so September may be a month with insufficient submissions Although the 60 anda submitted in September is lower than the average 71 submitted in fy2016, we may not see the impact of lower fees and 5-month review advantages until the end of the first few months of fy2017 If a significant number of andas are stranded and not submitted in the last quarter of fiscal 2016 to facilitate access to new review indicators and fees, the data for the next few months will be interesting In September, OGD issued 193 full response letters (CRL) which became the highest month in fiscal 2016 (the previous highest month was 190 in April 2016) In fiscal 2016, OGD issued 1725 CRLs, significantly higher than other years of gdufa phase I (about 500 higher) So what will companies expect in fiscal 2017? I guess their expectation will be a continuous increase in the number of approvals per month to close to a figure, probably close to 75-80 approvals per month They must expect to achieve more approvals than they receive, better information on communication, compliance status and solutions, and clearer guidance documents and OGD policies These are my guesses What about yours?