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FDA To Tackle Critical Generics Issue In Switch Paradigm Debate

 
• By Malcolm Spicer

Commissioner Hamburg says FDA asked for input on a “new paradigm” for nonprescription drug approvals in part because pharmaceutical firms have concerns about whether potential access restrictions imposed on an innovating switch would also apply to generic versions that eventually reach the market.

In its approach to developing a “new paradigm” for nonprescription switches, FDA is working on addressing a significant concern for potential sponsors: protecting innovators from potentially unfair generic competition.

FDA is collecting input on developing alternative routes to nonprescription drug approvals in part because pharmaceutical firms have expressed concerns...

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No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

 
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The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.

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Pink Sheet Podcast: FDA’s New Top Drug Regulator, Sarepta’s Options After Elevidys Stand-Off

 
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More from North America

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
• By Eliza Slawther and Sarah Karlin-Smith

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.

Merck’s Keytruda Gains Medicare Negotiation Reprieve With Expanded Orphan Exemption

 
• By Cathy Kelly

Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.

US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited

 
• By Derrick Gingery

The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.