On 8/6/2021, a Federal Register Notice (here) was issued announcing an extension of the period before FDA intends to begin enforcing the statutory 5 percent limit on out of state distribution of compounded human drug products. FDA is extending the period for states to decide whether to sign the final MOU, (“Memorandum of Understanding Addressing […]
In a Federal Register Notice scheduled to publish on Monday August 9, 2021 (see prepublication notice here), FDA indicates “[O]n April 16, 2021, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision in Genus Med. Techs., LLC v. FDA, 2021 U.S. App. Lexis 10928 (April 16, 2021). The U.S. Government […]
In previous posts here and here, we outlined the attack on the carveout provisions of the Hatch-Waxman Act (also lovingly known as the “skinny label”) that the crafters of the Act included to ensure that generic drugs could get to consumers if there were certain patents or exclusivity issues that would otherwise block entry into […]
While not down by much, the unofficial approval numbers are down yet again. The previous low for a month this FY was 58 (both full [46] and tentative [12] approvals). July saw only 56 (47 full and 9 tentative approvals). This is the third month in a row where the numbers have been well below […]
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 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 […]
