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 […]
In another flurry of guidance issuances, FDA has provided (what I thought would be) a really good read. I was hoping that the long-awaited Guidance for Industry: Determining Whether to Submit an ANDA or a 505(b)(2) Application (here) would have some new insight into choosing which regulatory submission path to follow; however, while being a […]
I disagree with FDA – how many times have you said that, but did not act because, 1) you did not know who to call, or 2) you just did not know the process? Under the GDUFA II program, there is actually a provision for reconsideration outlined in the GDUFA II Goal Letter (and if […]
Ever have a great idea and then do nothing about it? Well, our guest blogger Christopher Palombo, CEO, the Dispensary of Hope and his team not only had a great idea but are doing something about it. Below, Chris explains their mission and where they are today and where they hope to be in the […]
The Office of Generic Drugs (OGD) has long taken the position that calls from multiple industry representatives about the same application to different OGD review staff or senior staff do nothing but waste the time of OGD. This is definitely accurate; however, those multiple calls in the past were made because information was difficult (if […]
The FDA posted its final approvals and receipts numbers for FY 2017 today. We thought there might be a blip in receipts due to firms trying to beat the GDUFA II fee clock which took effect on October 1, 2017, and we were right. OGD received a whopping 202 ANDAs in September. This was not […]
The reauthorization of the Generic Drug User Fee Act GDUFA, which takes effect on October 1, 2017 and commences GDUFA II, has many significant changes relative to goal dates for ANDAs, amendments to ANDAs, and amendments to prior approval supplements. The system for classifying the goal dates has been simplified from a tiered system under […]
OGD has released a new Q&A document relative to refuse-to-receive issues. I must be quite frank, there were some questions and their answers of which I was not aware. Everyone submitting an ANDA should thoroughly review this draft guidance and assure that your ANDA conforms to all of the conditions specified in the document prior […]
Don’t need to get out your GPS because MaPP 5220.3 will help you understand how OGD plans to navigate the filing review to communicate major and minor deficiencies to the applicant in an information request (IR). If the minor deficiencies can be resolved within a 7-day period, then your ANDA has the chance to be […]
