While California is usually a very progressive state, I believe that Governor Newsom did not quite understand the implications of the bill he signed into law banning pay-for delay patent settlements. I believe he failed to see that not all pay-for-delay cases are anticompetitive. According to the Association of Accessible Medicines (AAM) statement about the […]
August saw the OGD refusing to receive only three applications, one standard application and two priority GDUFA II applications. Quite interestingly, thus far this FY, the number of priority-review applications compared to the number of standard-review ANDAs that have been refused to be received (10/37) is quite high considering that there are many more standard-review […]
In a short Warning Letter issued by the FDA on August 29, 2019, the Agency informed a China-based testing firm that, because it refused inspection, that FDA would withhold approvals of any ANDA or NDA in which it was cited as a testing laboratory. The FDA takes refusal of inspection very seriously and the impact […]
After a few inquiries about the lack of public approval action reporting for ANDAs at the end of August and thus far through September 25th, it appears that our reporting revealed some type of a problem. Although we do not know the exact nature of the problem as of yet, we received a nice note […]
Not wanting to really say we saw this coming, but in a blog post in October 2014 (here), we postulated that the abuse-deterrent aspect of other classes of drugs that have abuse potential would likely be become targets as time passed. In a Federal Register Notice (here), this prediction made in 2014 appears to be […]
So, what is the buzz about continuous manufacturing (CM)? What benefits does it bring to the manufacturer and what are the regulatory challenges? The author of this Contract Pharma article, José L. Toro, Ph.D. of Lachman Consultants, discusses the current thinking on the benefits of CM and the regulatory hurdles a manufacturer has to overcome. […]
The Office of Generic Drugs is publishing thirty-one new and fifteen revised bioequivalence guidances according to the pre-publication notice that appeared in the Federal Register today (here). The official FR notice is scheduled to publish on September 17, 2019, but a quick check reveals that the new and revised guidance documents are already available today […]
Oh, the games that are played to keep market share are becoming more curious every day. Just check out this article from Drug Topics penned by Louis Tharp and Craig Burton entitled Generics and Biosimilars Facing Formulary Difficulties (here). When Hatch-Waxman was passed, there were attacks on the bioequivalence of generic drugs, the quality of […]
For all Sponsors submitting INDs, NDAs, ANDAs, BLAs, and supplements, and the bioanalytical laboratories analyzing and reporting the data to support these submissions, the FDA just issued its Guidance for Industry, “Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers.” The Q&A guidance contains five questions, along with the Agency’s current thinking on […]
According to all of the published approval data on the FDA All Approvals List (here) and the Drugs@FDA: FDA Approved Drug Products (here), the OGD has taken full-approval action on fifty-nine ANDAs and tentative approval action on twelve ANDAs for a total of seventy approval actions in August. But wait – there is something amiss! […]
