We know that a regulation hold has been placed by the Biden Administration until they can review their positions on proposed regulations, but it is highly unusual that no FR notices have appeared since Inauguration Day, January 20, 2021. Many FR notices address issues other than regulations, including meeting notices, guidance announcements, collections of information […]
Looks like we all will be doing a lot of reading and assimilation of new information in 2021. The CDER Guidance Agenda – New & Revised Draft Guidance Documents Planned for Publication in Calendar Year 2021 contains 105 new and revised guidance documents that CDER plans to release this year. While there are a number […]
Goal dates extended, virtual inspections taking longer, and on-site inspections still too slow for industry. COVID is mostly to blame, but, once the vaccine is widely available, then maybe inspection activity will pick up further domestically and possibly even foreign inspections. Right now, the landscape is not pleasing to either FDA or the industry. High […]
So, here is my question – when will the Congress and the FDA get off their butts and do something about active pharmaceutical ingredients appearing in dietary supplements or the other issues with dietary supplements that occur over and over? This is not a new problem. We have posted about it numerous times here, here, […]
We were close on our unofficial approval numbers for December reported here for approval actions and tentative approval actions (63 and 20 respectively) as the official numbers reported today by OGD are 63 and 22, respectively. Looks like 2 TAs snuck onto the approvals listing late in the game. Of the 63 approval actions in […]
While reading a blog post by Michael Mezher of RAPS this morning, entitled HHS Pushes Through Last-Minute Policies Impacting FDA (here), it struck me that my own age old question is almost (and I stress almost) being addressed. The question is, when a regulation or statute directs the FDA to meet certain review timeline requirements, […]
In a continuing effort to deal with the number of ANDAs, supplements, and bioequivalence work and maintain a consistent and uniform quality of its reviews, the Office of Generic Drugs will be moving forward with a reorganization plan that will likely be effective sometime later in 2021. In the announcement received via email this morning, […]
As we hoped in our post here, the unofficial approval numbers for December were pretty good. As of postings on the FDA’s All Approvals list as of January 7, 2021 (here), OGD posted 63 full approval actions and 20 tentative approval actions for a total of 83, up from the November 76 total approval actions. […]
On December 28, 2020, we published a blog post on the OMUFA fee structure for new OTC reviews and facilities (here). Today, in the prepublication of the Federal Register (FR) here, the FDA abruptly withdrew the FR Notice. Looks like someone along the way goofed as the notice bluntly indicates that “[T]he Department of Health […]
Ever since November 24, 1984, the effective date of the Drug Price Competition and Patent Term Restoration Act (aka Hatch-Waxman) which created the unique and delicate balance between innovation and safe and effective high quality generic copies of brand name products, the use of the “skinny label” has been a touchstone of that balance. Rather […]
