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 […]
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 […]
In FDA’s just released report, Estimating Cost Savings from Generic Drug Approvals In 2017, the Agency points to some staggering savings to consumers from the generic drug applications it has approved. I have read through the report a number of times already, and must say I am not quite certain what the numbers actually mean, […]
OGD just updated its April 2018 statistics as it does before it reports the next month’s receipts and approvals. You can see all of the updated figures for April here, but there are a few things we think are noteworthy to point out. OGD only refused-to-receive (RTR) five (5) ANDAs in April, which was the lowest […]
The FDA has released its required annual report on 505(q) petitions. Such petitions are characterized by their intent to ask the FDA to either delay approval of an abbreviated new drug application, a 505(b)(2) NDA, or a biosimilar under 351(k) of the Act. Our good friend Kurt Karst, Director at Hyman, Phelps & McNamara, has […]
Yesterday, the FDA issued two draft guidance documents titled Development of a Shared System REMS (here) and Waivers of the Single, Shared System REMS Requirement (here). As the names may imply, if a shared system is possible, then that is the way an applicant should go, but if there are insurmountable hurdles to a shared […]
This formal ICH Guidance document (here) describes the entire post-approval lifecycle management of changes that are to be made after initial approval of a regulatory submission. The document is quite comprehensive but, as always, because of inherent differences in the various regulatory authorities, there are limitations to its universal application. As the guidance document notes, […]
