Well, June was apparently another good month for the OGD FDA work-from-home teams as the unofficial counts of the numbers show they managed 74 full approval actions and 5 tentative approval actions. The 74 full approval actions represented the highest total in a single month thus far in FY 2020, beating the next highest of […]
This morning I read Joe Graeden’s (The People’s Pharmacy) article titled “Can You Trust Generic Drug Quality” (here) and, as a former longtime senior official at the FDA who worked in the Office of Generic Drugs and have consulted for the industry for over twenty-five years, I had a kind of knee-jerk reaction and wanted […]
The FDA released an updated version of its Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry as Revision 2. Originally issued in 2015 (here) and updated again in 2019, the June 2020 version contains much the same information but provides updates as to timetables, additional categories of PAS, CBE, and CBE 30 […]
The Agency has provided an updated list of drug products that are off-patent and have no unexpired period of market exclusivity and have no generic product approved. The revised list contains a 2-part listing and an appendix. Part 1 contains 269 targets products for “those drug products for which FDA could immediately accept an ANDA […]
OGD approval numbers have surged through June 15th as OGD has already issued 44 full approval actions and 4 tentative approval actions. 14 of those full approvals came on the 15th and 16th of June. Six of those approval actions were for Deferasirox Tablets, 90 mg, a generic of Jadenu. It appears that the block […]
The Office of Generic Drugs (OGD) updated its April stats and notes 4 refuse-to-receive (RTR) actions (3 standard ANDAs and 1 priority application) which is in line with what we have seen so far this entire FY (months average for 7 months is 3.6 RTRs/month). OGD also acknowledged 65 new ANDAs in April. Of the […]
In an FDA new release (here), the Agency announced that it was pulling its EUA saying they “determined that the legal criteria for issuing an EUA are no longer met”. The Agency took this action after a review of the current state of knowledge on the two drugs relative to their unproven efficacy and serious […]
Today, the FDA posted MaPP 5220.2 (here), which outlines a little-known process (because it so seldom happens) that describes how the Agency will go about converting an ANDA approval to a tentative approval (TA). The issue only occurs when a patent challenge is won by the innovator after the expiration of the thirty-month stay and […]
When I started reading Kurt Karst’s blog post entitled “Code Orange – The Orange Book Archives Have Arrived” this morning (here), I thought, well, the FDA must have developed an archive of all of the old Orange Books (OB) and Kurt is announcing FDA’s good deed? Wrongo, beaver breath! It was Kurt and the folks […]
The FDA announced today the addition of 25 new bioequivalence (BE) recommendations and has issued revisions of 24 previous recommendations. FDA continues its efforts in getting ahead of the curve trying to issue BE recommendations for “(1) new chemical entities and (2) approved on or after October 1, 2017, at least 2 years prior to […]
