April 2024 FDA SBIA Generic Drug Forum - A Flair for the PLAIR - Lachman Consultants Blog

April 2024 FDA SBIA Generic Drug Forum – A Flair for the PLAIR

Last week, I was able to attend SBIA’s Generic Drug Forum in Bethesda, Maryland, and I’m sure that many readers of Lachman’s blog also attended virtually. The Forum offered a diverse array of presentations applicable to the generic industry at large. In this blog, I will focus on one presentation related to PLAIRs (Pre-Launch Activities […]

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Metal clean shelves in market. 3d rendering

The “Hows” of Drug Shortages 

If there was one theme that was pervasive throughout the discussions and presentations at the recent AAM Access 2024 meeting in Tampa, Florida, it was related to drug shortages.  The issue was touched upon by representatives from AAM, officials from the FDA, CEOs, Doug Long of IQVIA, and others as well.  With different individuals providing […]

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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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CHANGES AHEAD: Roadside sign: Trailer mobile warning sign parked by road with words for safety by orange cones

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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