Today, the Federal Register announced the 2022 MDUFA fees (here). As the FDA notes, “This notice establishes the fee rates for FY 2022, which apply from October 1, 2021 through September 30, 2022, and provides information on how the fees for FY 2022 were determined, the payment procedures you should follow, and how you may […]
Clozapine was one of the first drugs to have a “REMS” system in place to ensure safe use such that patients developing clozapine-induced severe neutropenia were precluded from getting the drug, which would do further damage, and, thus, avoiding potentially life-threatening scenarios. Initially, the REMS program was independently operated by the innovator and, once the […]
Everyone knew this day would come and it has been a long time in coming. Yesterday, the FDA approved the first interchangeable biosimilar for an insulin product. An interchangeable biosimilar, like an AB-rated generic product, can be substituted at the pharmacy without intervention of the healthcare provider. According to the FDA announcement, “Semglee (insulin glargine-yfgn) […]
In a Federal Register Notice today (here), the Agency announced the FY 2022 user fees for New Animal Drug Applications. While the application and certain fee-paying supplemental applications increased modestly, the remainder of the annual fees decreased. “Fees for applications, establishments, products, and sponsors are to be established each year by FDA so that the […]
The Federal Register announced the BsUFA fees for FY 2022 today (here) and, for the second year in a row, the fees have decreased or, in the case of applications, stayed the same. Fee Category Rates for FY 2021 Rates for FY 2022 Percent Change Initial BPD $102,494 $57,184 -44.3 Annual BPD $102,494 $57,184 -44.3 […]
Outsourcing facilities are compounders registered with the FDA under Section 503B of the Federal Food Drug and Cosmetic Act. They undergo FDA inspections and must follow cGMPs as they relate to compounded prescription drug products that they are authorized to compound. Good news for the 503B facilities – their fees have not gone up much […]
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 […]
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 […]
Happy July 9th! Hope you had a great Fourth of July weekend, but now it’s time to get back to business. The OGD seems to have squeaked by its lowest month totals of approval actions this FY (for May) as it appears to have recorded sixty total-approval actions for June, at least through the July […]
“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 […]
