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,
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 the year,
Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research recently proposed changes to CDER’s new drug regulatory program. The proposals (here) include regulatory and review process changes, as well as organizational restructuring. The drive behind these changes are to free up resources so that the reviewers have more time to focus on drug development.
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,
A number of years ago, I was reading a blog by Kurt Karst (here), the title of which included “A 505(b)(2) NDA in Search of a Basis for Submission and Approval…” Apart from the interesting details covered in the blog about how a product was received under the 505(b)(2) pathway, it highlighted a trend that was in the making.
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 outlined the history of 505(q) petitions and the issues addressed in the report here:
He did such a good job that we are not going to delve further into the numbers.
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 system,
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.
The U.S. Food and Drug Administration (FDA) approved a record number of generic drugs in the U.S. during the fiscal year (FY) that ended on September 30, 2017, with Indian companies accounting for nearly 40% of the approvals. While the FDA’s report does not give details country-wise, an industry analysis (here) of the monthly generic drug approvals company-wise indicated that Indian companies received a total of 295 out of 763 approvals.