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 […]
FDA has released its revised outline of specific generic drug research priorities for FY 2022 (see here) based on feedback of stakeholders in a public meeting held on June 23, 2021 as well as written comments received on the 15 proposed research priorities announced at that meeting and the issues that FDA sought comments on […]
In a news release on November 15th (here), the FDA announced that ”the U.S. Department of Health and Human Services withdrew a policy that directed FDA not to enforce premarket review requirements for laboratory developed tests (LDTs). This action will help ensure that COVID-19 tests are accurate and reliable.” The Trump policy was a misguided […]
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 […]
For those of us on the West coast, it was an early wakeup this morning, but well worth it! Here are some highlights from the GRx-Biosims conference morning sessions. Dr. Sally Choe, Director, Office of Generic Drugs (OGD), opened the morning with the OGD keynote address. Dr. Choe outlined the OGD’s performance during the pandemic, indicating that […]
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, […]
Another busy schedule for another virtual meeting. AAM has indicated that it will be back to in-person meetings with the February 2022 annual meeting. We are all looking forward to being able to shake hands, see each other in person, and chat face-to-face. Don’t know about you but, for me, virtual meetings just don’t have […]
Today, FDA issued a Federal Register notice (here) announcing the release of 24 new product specific guidances (PSGs) and 20 revised guidances. These guidances provide the FDA’s current thinking on the methods to establish bioequivalence for specific products. The new and revised guidances can be found on the FDA webpage here. Please note that, as […]
