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Complex Generics: Gottlieb Eyes FDA Policy Changes To Speed Approvals

 
• By Sue Sutter

US agency could reconsider requirement that instructions for use be same for branded and generic products, FDA Commissioner-nominee Scott Gottlieb suggests, while also leaving door open to statutory changes in Hatch-Waxman Act.

Syringes stuck in a dartboard

The US FDA should explore administrative steps within the existing Hatch-Waxman framework to smooth the abbreviated new drug application (ANDA) process for complex generics, but congressional tweaking of the landmark law might be necessary, commissioner-nominee Scott Gottlieb said at his April 5 Senate confirmation hearing.

FDA needs to “develop better scientific principles” for assuring substantial equivalence of ANDA products when traditional measures of bioequivalence may...

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• By Urtė Fultinavičiūtė

In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.

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The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.

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Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

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‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
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The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.