18
Nov

November FY 22 Mid-Month Generic Approval Outlook and Final October Official Approvals

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 […]

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10
Nov

AAM Meeting Day 3

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 […]

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10
Nov

AAM’s GRx-Biosims Day 2 – Afternoon Sessions 

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 […]

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09
Nov
Back view business woman raising hand for asking speaker for question and answer concept in meeting room for seminar

AAM GRx-Biosims Meeting – Day Two, Morning

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 […]

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08
Nov

FDA Announces the Issuance of New PSGs

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 […]

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04
Nov
Red arrow. Vector

Unofficial OGD Approval Figures for October 2021

Well, the first month of FY 2022 appears to be an improvement over the last month of FY 2021, which was reported as forty-nine total approval actions, as the OGD hit an unofficial total of sixty-two in October 2021.  The total is broken down into fifty full-approval actions and twelve tentative-approval actions.  Usually, a few additional […]

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31
Oct

OGD Published GDUFA III Commitment Letter

Every 5 years, the user fee programs (UFAs) are renegotiated and, for each UFA program, there is a commitment letter that outlines the agreed-upon goal dates and program enhancements that will dictate the five-year reauthorization period when Congress passes the Reauthorization Act (likely in mid to late FY 2022). This is a piece of must-pass […]

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