“Surprise” seems to be the best word to describe the updated May statistics report regarding the issuance of refuse-to-receive actions (RTR), which was reported as eleven (eight for standard ANDAs and three for priority ANDA submissions). It has not been since June 2018 that so many RTRs were issued. There is no telling whether this […]
In previous blogs (here, here, here, and here), we discussed abuse-deterrent formulations and the potential “creep” in applying this approach towards substances other than opioids. So far, we have not seen a big move in that direction, most likely because of the lack of any great success of currently approved abuse-deterrent formulations from actually preventing […]
Overnight, the FDA posted its official approval numbers for May 2021 and the picture is not great. We reported in a previous blog post (here) unofficial totals of full-approval actions at forty-five and tentative‑approval actions at thirteen. We missed by one on each as the official numbers revealed forty‑six full‑approval actions and twelve tentative-approval actions […]
The last post we did on this list was back in June 2020 (here ) and there were 269 products on Part I (those that firms can immediately submit an ANDA) and 136 on Part II (those products that may be more difficult and present various regulatory or scientific issues and for which FDA recommends […]
We have reached the halfway mark of June and, as of the unofficial reporting through June 15th,OGD has issued just 24 full approval actions and 7 tentative approval actions. Two ANDAs received partial full approval with at least one other strength receiving tentative approval, likely because of patent or exclusivity issues. The count for the […]
We last posted on Competitive Generic Therapy (CGT) approvals in the beginning of April (here) when the Office of Generic Drugs reported 80 approvals for CGT ANDAs. In its latest report (here), that number has jumped to 90, with the approval of ten (10) additional ANDAs approved through the CGT program. Of the ten (10) […]
The Office of Generic Drugs (OGD) filled in the blanks on its April Generic Drugs Program Activities Report – Monthly Performance (here) and here are the highlights of some of the important numbers. OGD issued refuse-to-receive (RTR) to three (3) ANDAs, all of which were for standard review ANDA submissions, while acknowledging seventy (70) new […]
Well, it was May gray, as reported in our previous post (here),as OGD full approval actions plummeted in May to just 45, the lowest this fiscal year and all the way back to June 2019. Tentative approval actions projections for May are 13, bringing the total approval actions for May to 58. That is the […]
The Agency today published four draft guidance documents to assist sponsors to better understand the terms and conditions of certain aspects of the Supply Chain Security Act requirements. The draft and final guidances are as follows: Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act – This […]
In a Federal Register notice today (here), the FDA blasted the HHS under the previous administration for withdrawing the Unapproved Drug Initiative (UDI), citing misstatements, errors of law, and fundamental untruths in the original Federal Register notice, published on November 25, 2020, titled “Termination of the Food and Drug Administration’s Unapproved Drugs Initiative; Request for […]
