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 from the FDA press office.
I have blogged about a problem with the discrepancy in the official August approval numbers that the FDA issues in its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (Report) (here) and those appearing on the FDA daily approval list (here) and the FDA All Approvals list (here).
This guidance (here) finalizes the draft guidance for industry entitled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act” issued in October 2018 and supersedes the Guidance by the same name issued in November 2014. The guidance document revision is based on comments that were submitted to the Agency after the original draft was introduced in 2018.
Recently, the United States Pharmacopeia and National Formulary (USP-NF) announced a three-month public consultation period on a proposal to change the approach to impurity reporting thresholds for drug products and drug substance monographs[i]. This activity is part of the USP-NF’s ongoing efforts to ensure that monographs reflect technical advances and current regulatory expectations.
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 (September 16th) on the Product-Specific Guidances for Generic Drug Development (here).
OGD published their official approval actions for August and the Agency posted 66 full approval actions and 13 tentative approval actions in its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here). However, the FDA All Approvals list (here) for August lists 59 full approval actions and the correct number of tentative approvals (13).
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,
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 each topic.
The Office of Generic Drugs provided an update late last night to its Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here). Not too many surprises, but there are a couple of numbers that are of interest.
Let’s start with refuse-to-receive (RTR) actions. There were only two RTR actions in July (both for standard review applications),
This morning after reading an article in the Pink Sheet entitled US FDA Urged To Stop Slowing Approvals By Seeking Metals Data From Suppliers written by Joanne S. Eglovitch, my mind harkened back to the early 2018 slowdown (and almost stop) in ANDA approvals based on the elemental impurities issue (see earlier post (here).
I don’t know about you but has this year flown by or what? Summer will be over on Labor Day and there will be only one month left in FY 2019. OGD approval actions thru reporting on August 22 show OGD with 53 full approval actions and 11 tentative approval actions. Thus, it looks like OGD will beat the last two fairly slow months that had total approval actions of 62 (45 full and 17 tentative),