In my 44 years in the industry, I don’t think any issue has raised as many questions, caused companies to scratch their heads or raised the level of angst more than the issue of the dreaded Field Alert Report (FAR). Well now – and finally – the FDA has issued a Q&A document that answers many of those head- scratching questions.
When an NDA holder lists a patent in the Orange Book (OB), it sometimes appears that the patent listing use claim, or other information is challenged by prospective ANDA applicants. FDA has updated its Listing of Patent Disputes (here) through July 13, 2018. This is the first time that we have seen this list (maybe we were asleep at the switch),
Very seldom do we see a notice of recall that relates to a change in the manufacture or processing of the Active Pharmaceutical Ingredient (API), but that is what appears to have happened in this instance. The FDA announcement states:
The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan,
This goes in the “where did this come from?” category. In an earlier post on July 5th where we looked at the available data on the FDA daily approvals and All approvals page for the end of June 2018, we only came up with 67 full and 6 tentative approvals (TAs) actions (see post here).
OGD updated its monthly Activities Report Of the Generic Drug Program FY 2018 for certain statistics that had not yet been posted (here). While we wait for the June 2018 official approval and receipt figures, let’s have a look at some of the interesting May statistics.
OGD reported 8 refuse-to receive (RTR) actions,
As far as the available numbers for ANDA approvals and tentative approvals goes, for June, it appears we will have in the neighborhood of 67 full approvals and 6 tentative approvals for the month, more or less in line with what we have seen in the past few months. These numbers were derived from the FDA All Approvals list (here) and the FDA Approved Drug Products list of daily approvals (here).
Today, as a 4th of July present, and in anticipation of celebratory fireworks, the FDA has issued a final guidance entitled ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA (here). The final guidance explains that the complex tiered amendment classification system of GDUFA I was abandoned to provide a less cumbersome and more straightforward classification of amendment types,
On June 25, 2018, the Association of Accessible Medicines (AAM) submitted comments to Docket FDA-2017-N-6644: Generic Drug User Fee Amendments Reauthorization of 2017; Regulatory Science Initiatives; Public Workshop and provided some very interesting and relevant comments and suggestions. The full text of the AAM comments can be found here, but here is a peek into the basket of suggestions.
Late yesterday, Dr. Douglas Throckmorton, Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, issued a statement on the FDA’s ongoing efforts in the area of drug shortages. Based on our post yesterday (here), which outlined the FDA’s new report on drug shortages for 2017, we felt it was necessary to provide a link to Dr.
Those of us who were around in the Regulatory Affairs field during the late 90s probably remember the glory days of ESD, EVA, and CDOC, following the years of page-stamping in hallways that resembled assembly lines. Then came EVA, which was part of a system called the Electronic Submission Program, which was in turn, part of a larger strategy for electronic regulatory submission and review at the FDA.
The Hill reports (here) that there are close to 50 Bills pending before Congress that are expecting action by the end of the week, to help address the opioid epidemic. It is the hope that a comprehensive package will be put together and ultimately be passed into law.
Providing a legislative foundation to the cause is a good start,
The Report on Drug Shortages for Calendar Year 2017 (here), which is required by Section 506C-1 of the Federal Food, Drug and Cosmetic Act, issued last Thursday, and describes some real progress in the drug shortage arena.
The report notes that “][d]uring 2017, FDA helped prevent 145 potential new shortages,
The current Submission Status Snapshot which was published yesterday (here) describes the current OGD workload. It is broken down into two major charts, the Pre GDUFA Year 3 applications and the current Total OGD Workload chart. Why? Remember that pre-year 3 applications did not have goal dates like those that were submitted pre-GDUFA (the old backlog ANDAs).
Well, who will be changing categories (small, medium, and large) for assessment of year two of GDUFA II program fees? The FDA asks “[i]n preparation for the FY 2019 GDUFA Generic Drug Applicant Program Fee, please confirm your affiliates and approved ANDAs owned by you and your affiliates as soon as possible.”
In the first 7 months of FY 2018,