Today FDA has warned consumers (here) that the products listed below that are offered for sale in the US contain undeclared active ingredients that can be dangerous for some users. This is not really a surprise as unscrupulous manufacturers and distributors try to cash in on patients with erectile disfunction or on users that merely […]
In a Federal Register Notice, FDA explains that ephedrine sulfate and hydroxychloroquine sulfate are not to be included on the bulk drug list for use in compounding by 503B outsourcing facilities (here). As mentioned by the Agency “[O]ne of the conditions that must be met for a drug product compounded by an outsourcing facility to […]
Well summertime and its usual vacation schedule has not put a damper on ANDA approval actions and thus, I am happy to report that posting through August 16th reveal that OGD has issued 41 full approval actions and 7 tentative approval actions. If this pace keeps up for the rest of August, this will be […]
On August 8, 2023, Axios reported (here) that the Pentagon began contracting with Valisure, a drug testing facility, to test the generic drugs that it is purchasing. On August 9, 2023, Bloomberg reported much the same thing in an article titled “Tainted Medicine Fears Spur Pentagon to Seek Outside Testing” (here; subscription required). Congress has been pushing […]
According to currently published figures as of July 6, 2023, OGD has issued 68 full approval actions and 15 tentative approval actions for a total 83 total approval actions for the month. The 68 full approval actions represent the third highest number per month for the 10 months of FY 2023 and the 83 total […]
The Food and Drug Administration (FDA) has announced the fiscal year (FY) 2024 rates for the establishment and reinspection fees related to entities (503B registered facilities)” that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act authorizes FDA to assess and […]
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 […]
