Exclusivity from the Experts

One of the breakout sessions offered at the recent FDLI conference was titled, Updates on Patent and Exclusivity Issues for Drugs, Orphan Drugs and Biologics.  The panel for this session included representatives from FDA, industry, and attorneys that specialize in this practice area.  While the session covered both patent and exclusivity issues, I will be […]

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Will There Be Changes to FDA’s Post-Approval Changes Guidances?

One of the closing sessions at the recent Association for Accessible Medicine’s GRx + Biosimilars conference covered Post-Approval Changes to Complex Generic Drugs.  The session included presentations from multiple individuals from FDA, as well as from industry, to provide a breadth of perspective on this subject. As one would expect, the session did offer both […]

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The User Fee Reauthorization Passed – The President Signed the Bill Into Law – But Still No Word on Where That Leaves the Industry

While passage of the Continuing Resolution by Congress on September 30, 2022 and corresponding reauthorization of user fees for the different programmatic areas is a relief, the extremely late passage of the Bill leaves FDA and Industry in an awkward position in relation to one of the most important elements of the reauthorization-submission of applications […]

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