Today, the FDA published the eighth revision of a guidance titled Part VI: Impurities: Residual Solvents (Maintenance): PDES For 2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tertiary-Butyl Alcohol (here). This revision adds the three residual solvents named above and provides permitted safe daily exposure (PDE) limits for patients. The guidance provides information on the solvents themselves, 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 […]
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 […]
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 […]
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, […]
