As of the postings both on the FDA daily approvals list (here) and the FDA All Approvals List (here), the morning of December 3, 2019 OGD lists 49 full approval actions and 8 tentative approval actions for a total of 57 approval actions for month two of FY 2020. October has a final official approval […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
In the prepublication page of the Federal Register Notice (here) published today, OGD announced 28 new bioequivalence recommendations and revised 53 previously issued recommendations. While the new and revised guidance documents appear on the listing of Product-Specific Guidances for Generic Drug Development (here), the links to the new and revised documents were not yet active […]
OGD reported the official approval actions, receipts, and Complete Response Letters for the first month of FY 2020. There were 57 full approval actions and 8 tentative approval actions for a total of 65 approval actions for the month of October (we reported 52 and 9 actions respectively here), so it appears that there were […]
With the FDA reporting posted through November 18th, the OGD has issued full-approval actions for just twenty-four ANDAs and has issued tentative approval actions for two ANDAs. Thanksgiving week is a notoriously slow week for approval actions due to the holiday and staff absences, so November looks like it will be a somewhat lean month […]
There have been eighty-six first-time generic approvals for the calendar year 2019 thus far, at least through November 8, 2019, according to the updated list by the FDA (here). The FDA wants us to remember that first approvals do not always translate into products that are immediately available to the public due to either patent […]
On Wednesday afternoon at AAM’s GRx+Biosimilars Conference in Bethesda, MD, the FDA held a valuable workshop on Complex Generic Drug Products. The workshop opened with a general session explaining the opportunities for interacting with the FDA to get guidance and input while developing your complex generic and preparing your ANDA and how to get the […]
On the last day of at the Association for Accessible Medicines GRx-Biosims conference in Bethesda, members of the FDA joined industry for an informative and interactive discussion on post-approval supplements. Dr. Paul Schwartz and his colleague Olugbenga Okubadejo expressed satisfaction with the current state of the post-approval supplement process, as well as the example of […]
An interesting session during the GRx+Biosims conference held in Bethesda on November 4, 2019 addressed Drug Substance and Drug Product Manufacturers – Partnering to Improve the Process. The presentations from the FDA, as well as industry, acknowledged that the adequacy of drug master files (DMFs) for APIs in one cycle has been a lot more […]
At the Association for Accessible Medicines GRx-Biosims conference currently ongoing in Bethesda, FDA called on Generic firms to be involved and participate in innovation and FDA’s Emerging Technology initiative. We heard that innovation was not something that should be limited to just Brand Companies. But, in the field of Generics, where Q1/Q2 and sameness or […]
