The schedules for the 2024 Biosimilar User Fees (BsUFA) (here) and Medical Device User Fees (MDUFA) (here) have been posted on the Federal Register prepublication page and are scheduled for final publication on August 28, 2024. BsUFA Fees The Biosimilar User Fee Amendments of 2022 (BsUFA III) authorize the FDA to assess and collect user fees for […]
The PDUFA user fees all rose, not much of a surprise! However, we are now getting into some serious money to submit a new NDA. These fees could (in some instances) deter smaller applicants from entertaining NDA submissions as they might price them right out of the market. And if it is not the NDA […]
On the Federal Register (FR) prepublication page today, the FDA outlined the new fee schedule for generic drugs under the GDUFA program for FY 2024. Make sure you have a bottle of Maalox nearby before you read the rest of this blog as the increases, especially for the program fees, might cause you some agita. Generic […]
Back on January 30, 2023, I wrote a blog (here) concerning a petition that was filed by Vanda Pharmaceuticals regarding a perceived difference in labeling between the brand and generic drug. In this case (and please see original post to familiarize yourself with the details), the firm claimed that the generic excluded braille from its […]
The Agency announced today the first approval of a drug (Ycanth [cantharidin]) available for the treatment of molluscum contagiosum, a viral skin infection that is fairly contagious and is spread by direct skin-to-skin contact. It is approved for use for adults and pediatric patients two (2) years of age and older. However, most infections occur […]
With the latest news that a tornado severely damaged a Pfizer sterile injectable plant in North Carolina, it is clear that Mother Nature is yet another interloper into the drug shortage problem in the United States. Ed Silverman, of the publication STAT, reports that “Among the damaged buildings was a Pfizer plant in Rocky Mount, […]
After a slow start to the month, the steam is beginning to power up and halfway through July, OGD has issued 32 full approval and 9 tentative approval actions, so it looks like it should wind up being a good month if the last week’s proliferation of approvals continues. These figures represent postings of Approval […]
Biosimilars are advancing the cause of affordable medications; however, in some instances, patient savings do not appear to be the primary concern of Pharmacy Benefit Managers (PBMs). The Association of Accessible Medicines (AAM) points to the fact that “[j]ust two weeks ago, the U.S. biosimilars industry entered a new phase when eight biosimilar versions of […]
The FDA answers this question in a newly released guidance titled Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act (here). “[H]olders of applications for human prescription drugs (hereafter applicants) who are required to conduct postmarketing studies or clinical trials under section 505(o)(3) of the […]
I remember working part-time as a pharmacist when I was at FDA and there were only a few prescription oral contraceptives that were available for dispensing at that time. If you had asked then (1984) if I thought that there would ever be an OTC version of an oral contraceptive available, I would have bet […]
