“Part 111 (21 CFR part 111) establishes the minimum Current Good Manufacturing Practice (CGMP) necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement.” 21 CFR 111.75(a)(1) of these regulations provides a process whereby a dietary supplement manufacturer can petition the Agency for an exemption for 100% identity testing for dietary ingredients.
The FDA issued its quarterly report on the progress of the generic drug program today and it provides a further look into the mean and median times for approvals for ANDAs.
The bounce in mean and median approval times, both up and down, relate to the specific approval cohort of the ANDAs to which the application belongs.
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,
FDA Commissioner Scott Gottlieb issued a statement (here) on the Agency’s continuing position related to compounded drugs for patients that cannot use an FDA approved product. However, the bent taken in his statement leans more towards the issues of safety and efficacy, while he points to the Department of Justice’s (DOJ) recent healthcare fraud enforcement actions related to the use of multi-component compounded products thought to artificially increase billing rates for these compounded products.
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.
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.
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.
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,