The generic community sprung into action with amicus briefs filed by the Association of Accessible Medicines and letters written by various other organizations to challenge the attack on the skinny label. Teva was able to convince the Court of Appeals for the Federal Circuit to rehear its skinny label case. Clearly, Congressional intent and regulatory […]
Today, The Hill hosted a webinar called “Complex Generics & the Prescription Drug Landscape.” Many thanks to The Hill for their efforts. The takeaway messages from the program participants are important, especially as the current Generic Drug User Fee Amendments III (GDUFA III) negotiations are revving up for the Office of Generic Drugs’ review and […]
We all can see from the OGD metrics that ANDA submissions and approvals have leveled off and have even gone down recently. In the negotiation meetings between FDA and industry for GDUFA III, it seems the Agency recognizes this, but there are some things that don’t seem to make sense and one item that is […]
As you know, we try to track the ANDA approval actions and report on other OGD metrics as closely and as early as we can to try to give you the most current and most timely information. The one thing we have found that the generic industry, as a whole, is most interested in are […]
We are two-thirds through the reporting workdays for the month of January 2021 and OGD has reported 35 full approval actions and 4 tentative approval actions (total 39). If the pace of approvals does not pick up in the last 6 reporting days, we are set to have a total of full and tentative approval […]
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 […]
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. […]
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 […]
