Well after the first 5 years of GDUFA I, we now have a comparative look at all 5 years for various metrics reported by the FDA in their Activities Report of the Generic Drug Program. In the chart below the 5- year highs are bolded and some trends can be seen. For instance, the number […]
Remember certain GDUFA fees were assessed on October 1, 2017 including the new FDA program fee and establishment fees. The FDA published arrears lists today and there are a lot of folks on those lists. If there is an error or if you need to pay the fee you should either rectify the situation quickly […]
On Friday October 27, 2017 FDA issued a draft guidance (as titled above) providing direction to firms relative to the assessment of user fees under GDUFA II. There are a number of hidden landmines relative to fee payment, especially relative to the program fee and reminder information about requests to withdraw an ANDA and its […]
There has been a ton of news in the pharmaceutical world this week so I thought I would diverge from my usual posts to provide some brief sound bites of things that caught my interest and will hopefully catch yours. First off, remember the New England Compounding Center (NECC) and the meningitis outbreak of 2012? […]
Now, I usually don’t try to second guess the FDA, and I certainly do not know much about the Center for Tobacco Products. In addition, I do not condone underage smoking, nor do I condone smoking at all and consider it one of the most significant threats to public health. The complaint (here) seeks a […]
In a notice on the CDER webpage today, FDA published 32 new draft bioequivalence recommendation documents and revised 19 previously published recommendations. The list of new draft guidance documents contained two powder for inhalation products (dry powder Inhalers, [DPI]) which represent what the FDA would term “complex products”. The two DPI recommendations, one for salmeterol […]
Got my NDAs and ANDAs a bit mixed up in this morning’s post (here) regarding potential first cycle approvals for ANDAs. The 8-month tentative approval for NDA 210064 was for a 505(b)(2) application and not an ANDA. Let’s give credit where credit is due to the New Drugs Review Division for that one. But the […]
In browsing the FDA generic approvals for October so far, there are some ANDA numbers that immediately caught my eye. ANDA 210064, which was tentatively approved on October 12, 2017, was, according to the tentative approval letter (here), received by FDA on December 16, 2016. That is an 8-month tentative approval. There is another instance, […]
We all are aware of the new fee schedule for GDUFA II which include: One-time fees: ANDA application DMF application Annual fees: Facility fees, both API and FDF ANDA holder fee Timeline for payment of the fees for ANDAs is at the time of submission of the ANDA. Payment of the annual Program Fee, Facility […]
For those of you who read my blog post on September 13, 2017 (here), the new fee structure for NDA and certain BLAs may have come as quite a shock, especially if you don’t normally play in that sandbox. Well, apparently a lot of folks must have had questions too, as FDA just published a […]
