August saw the OGD refusing to receive only three applications, one standard application and two priority GDUFA II applications. Quite interestingly, thus far this FY, the number of priority-review applications compared to the number of standard-review ANDAs that have been refused to be received (10/37) is quite high considering that there are many more standard-review […]
In his article “Endo comes out on top in its fight with FDA and bulk compounder” published in Fierce Pharma (here), Eric Palmer has pointed to a potentially precedent-setting decision that may have further implications for the outsourcing compounding community. The FDA has a long-standing policy regarding the marketing of unapproved drugs after the first […]
In three separate Federal Register Notices, the FDA announced the fee for the use of certain priority‑review vouchers (here, here, and here). Priority-review vouchers are awarded to a firm that that gains approval for a designated tropical disease, a material threat medical countermeasure, or a designated rare pediatric disease when an application is approved for […]
CDER’s reorganization of the Office of New Drugs initiative was begun in 2017 and today the FDA announced it (here). The goal was to increase the therapeutic areas more efficiently with a corresponding concentration of areas of expertise. The FDA says, “the changes increase the number of OND offices that oversee our review divisions from […]
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 […]
Not wanting to really say we saw this coming, but in a blog post in October 2014 (here), we postulated that the abuse-deterrent aspect of other classes of drugs that have abuse potential would likely be become targets as time passed. In a Federal Register Notice (here), this prediction made in 2014 appears to be […]
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). The latter two listings […]
This guidance (here) finalizes the draft guidance for industry entitled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act” issued in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 […]
So, what is the buzz about continuous manufacturing (CM)? What benefits does it bring to the manufacturer and what are the regulatory challenges? The author of this Contract Pharma article, José L. Toro, Ph.D. of Lachman Consultants, discusses the current thinking on the benefits of CM and the regulatory hurdles a manufacturer has to overcome. […]
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. In 2016, […]
