This is the first month of GDUFA III and thus the first month of FY 2023! For approval actions posting through October 19th which include approvals posting through October 17th (postings are usually one or two days behind the actions taken), OGD has issued 22 full approval actions and 6 tentative approval actions for a […]
With the coming of GDUFA III, many guidance documents have been changed, and new guidances have been released to address new issues under GDUFA III. We have published posts describing many of the changes and now the FDA has issued an updated guidance on prior approval supplements (PAS) (here). The above‑cited guidance replaces the October 2017 guidance of […]
There is no question that GDUFA III has brought with it a lot of changes. OGD has begun issuing Guidances and MaPPs to reflect the changes and updating those document that were issued under previous iteration of GDUFA. Rather than trying to paraphrase each Guidance and explain what changes have been made in the past […]
Congressman A. Donald McEachin (VA-04) comments “Today, [I] introduced the Updated Drug Labeling for Patient Safety Act, legislation to direct the Food and Drug Administration (FDA) to allow generic drug manufacturers to update their product labeling with safety-related information.” (see here). He notes that “[T]he Updated Drug Labeling for Patient Safety Act is commonsense legislation […]
All indications seem to be that all the User Fee reauthorizations (loving known as the UFAs) will be passed in a fairly clean bill by the end of the week. This is great news for FDA employees and for industry; however, we sure hope that they tell us what to do as that will basically […]
According to Zachary Brennan’s story on Endpoints (here), Sally Choe will be leaving OGD in two weeks coinciding with the end of GDUFA II and the beginning of GDUFA III. The interim Director will be Susan Rosencrance “who’s currently director of the FDA’s Office of Lifecycle Products in the Office of Pharmaceutical Quality and has […]
I read a great article by Joanne S. Egolvitch in the RAPS Regulatory News this morning about elimination of Citizen Petitions for TE ratings for 505(b)(2) products (here). The issue centers on the FDA’s (kind of wonky) requirement that 505(b)(2) applications with minor formulation changes requiring them to be submitted as an NDA also require […]
Based on a strong start to the month, the OGD has issued forty approval actions but only two tentative approvals based on information posted through September 20th. Sorry that this mid‑month review was a bit late; with about two‑thirds of the month gone, I don’t expect to see another month like those we’ve seen lately. […]
Well, OGD has snuck in one additional full approval and one additional tentative approval from the unofficial numbers we reported on September 6th (here). So, in actuality, FDA full approval actions for August were 75 and tentative approval actions were 22 for a whopping total of 97 (2 more than we found in available public […]
The FDA released a draft guidance titled Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products: Guidance for Industry (here) which, not surprisingly, addresses the requirements for statements of identity and strength designations on the principal display panels (PDPs) of OTC drug products. The guidance notes that “[T]he […]
