The Federal Register today provided the snapshot of generic drug user fees for FY 2022 (here) and the flash may blind you as some new fees have popped up and the program fees have actually decreased, but not by much! FEE CATEGORY FY 2021 Fees FY 2022 Fees % Change Applications Abbreviated New Drug Application […]
Well, with the only reported number that is up this month being for the receipt of new ANDAs (seventy‑six, the third highest number of new ANDA submissions in a month thus far this FY), I think we have some head‑scratching to do. Should the current rate of new ANDA submissions continue in the fourth quarter, […]
The trade press has reported that at least three of the major four user fee acts (UFAs) are close to wrapping up negotiations for the new five-year reauthorization period beginning in October 2022, but we have not heard where GDUFA III is in the process. As noted in a previous post (here), we wondered why […]
“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 […]
Paul Mason, Ph.D., Lachman Consultants, wrote an article for Contract Pharma covering “The Importance of Data Integrity Risk Assessment.” Here is a brief excerpt from the article: “The FDA and other Health Agencies have an expectation that companies understand the capability of their systems that generate and store data/records including any data integrity risks associated […]
FDA has worked with companies to support expiration date extensions for “critical” drugs on the FDA’s drug shortage list. The current list (here) contains 343 entries Most products have had their expiration dates extended by one year from the labeled expiration date. The list provides information to providers to verify that the firm had submitted […]
In a 33-page report titled Assessment of the Use of Patient Experience Data in Regulatory Decision-Making prepared by Eastern Research Group (here), the views of the FDA and its stakeholders (patients, industry, and physicians) are either leaning towards “we are just figuring it out” (FDA) or “we have no real idea how the Agency utilizes […]
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 […]
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 […]
