The first Activities Report of the Generic Drug Program FY 2018 (here) issued today and it is a record breaker for approvals and Complete Response Letters (CRL).

FDA broke the 100 mark with 101 approval actions with 87 full approvals (AP) and 14 tentative approvals (TA) (we predicted about 84 APs and 13 TAs back on November 2nd (here ). This beat the previous record of 100 approval actions (88 AP and 12 TA) back in June of 2017.  Hopefully this fast start to the fiscal year will continue.

More good news- OGD only received 65 ANDAs in October of 2017… albeit after the 216 they received in September.  Don’t know if that means that the next couple of months will be lower, considering the September rush to beat the increase in the ANDA user fees.

OGD also crushed the old record for CRLs, issuing 325 in October.  That is more than 125 more than ever before.  Could this be indicative of the shorter 10-month goals date driving more FDA responses to CRLs than approvals?  We will have to sort this out as we see more data from the 10-month goal date applications!

The new Activities report cited above also will be reporting may more metrics, like first cycle APs and first cycle TAs, acknowledgement letters, information requests and discipline review letters, pre-submission facility requests, among others.

Looks like we will have much more to talk about and digest each month!  I know I am looking forward to parsing the numbers, how about you?