FDA approval actions listed through December 15th include only seventeen full‑approval actions and six tentative‑approval actions for a total of twenty‑three total approval actions. As it stands, if these numbers represent one half of a month, it would mean that, at the current pace, we would see forty‑six total approval actions for the month of […]
Today, the FDA published an update to the list of non-patented drug products and products that are protected by exclusivity provisions. The new twist in the current version of the list is that it is in two parts. One part covers prescription drug products and the other covers OTC products that are FDA-approved. The list […]
On December 10, 2021, the FDA issued a guidance titled Cover Letter Attachments for Controlled Correspondences and ANDA Submissions, which can be found here. The guidance suggests that ANDA applicants can help their own causes by utilizing a checklist as an attachment to the cover letters of ANDA submissions and controlled correspondences submitted to the […]
FDA and industry have long wrestled with appropriate dissolution methodology for injectable suspension products. Investigations into the relevance of the dissolution methods utilized has shown wide variation in in vivo results despite consistent in vitro performance. As FDA notes in a recent article (here) on the new potential improved method developed to address “gaps between […]
Well, OGD is back over the 70 mark for total number of approval actions in a single month, with what appear to be at least 72-66 full approval actions and six (6) tentative approval actions reported, going by the numbers posted at 11 AM EST December 3 on FDA’s website. The last time OGD had […]
Well, a day more than halfway through November and the approval pace, at least for full approvals, has been brisk. Through those approvals and tentative approval actions posted through November 16th on the FDA All Approvals list (here) there have been 38 full approval actions and only 1 tentative approval actions. November has at least […]
The morning sessions opened with the usual USP presentation, which described its efforts domestically and globally and its goals for establishing quality metrics for products. After USP’s presentation, Christine Simmon led a manufacturers’ roundtable called Ensuring Biosimilars Sustainability. The discussions focused on the impact of rebates and the uptake of biosimilars. The group agreed that […]
The afternoon sessions of the conference that I was able to attend included a discussion of Combination Products and Similarity, and two legal-based sessions, one on Approval Pathways for Complex Generics – 505(j) vs. 505(b)(2) and the other on Generic Drug Case Law. The combination product similarity session described the various permutations of the sameness […]
The other session that I was able to monitor was the Cares Act – Additional Reporting Requirements for Manufacturers. The purpose of the new reporting requirements is to proactively identify potential drug or API shortages so that the FDA can begin to act and perhaps institute a flexible regulation approach to mitigate the shortage. The […]
Since I am not a superhero and am unable to be in two places at once, I had to choose which of the afternoon sessions I would attend. With one of the hot topics being the inspectional issues raised by the COVID-19 pandemic, I chose to sit in on the Post-COVID Inspection World: New Tools, […]
