Well, not only were we close, but we also hit the approval numbers for July on the head with 46 approvals and nine tentative approvals. While we reported 47 approval actions in our August 5, 2021 post (here), there was one July approval for a product with two strengths that are separately reported as approval […]
After a stop-and-go where the FDA pulled back an earlier Federal Register (FR) notice due to an issue with the calculations, the new PDUFA fees have been announced in a pre-publication of the FR here. So, this ends the announcements for the 2022 UFAs and you can take that to the bank! The new PDUFA […]
In today’s prepublication of the Federal Register listing (here), there is a notice asking for stakeholder comments on the treatment of pre-1962 applications approved as ANDAs that were actually (unbeknownst to most) submitted under section 505(b) of the Act and approved under section 505(c) of the Act, like an NDA. The historical issues leading to […]
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 […]
