Over a decade ago, the FDA issued a final report on Pharmaceutical Quality for the Twenty-First Century. As time moved forward, this led to the FDA’s Center for Drug Evaluation and Research through the creation of the Office of Pharmaceutical Quality, to launch “FDA Pharmaceutical Quality Oversight: One Quality Voice” (here), which attempts to develop […]
First issued in June of 2017, the FDA has updated the List of Drug Products Without Competition (here). The “List” also includes an Appendix that removes 11 products because approvals of a generic have occurred since the initial publication of the List. We first reported on the “List” here, and it has taken only two […]
The revised version of the 2011 Draft Guidance (here) “describes (1) the types of waivers, refunds, and reductions available under the user fee provisions of the FD&C Act, (2) the procedures for requesting waivers, refunds, or reductions, and (3) the process for requesting a reconsideration, or appeal of an FDA decision. The Draft Guidance also […]
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 […]
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 […]
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 […]
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, and there were 39 new […]
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 […]
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 […]
The official numbers of approvals and receipts are out for May 2018. OGD fully approved 67 ANDAs (one more than last month) and tentatively approved 19 ANDAs (which was six more that we found prior to the final posting) for a total of 86 approval actions. Given these numbers, if we straight-line the approvals for […]
