Nuplazid's Black Box: Warning May Depend On Antipsychotic Classification

Advisory committee questions whether an antipsychotic drug class boxed warning should go in the Nuplazid label if it is approved; some debate whether the product is part of that class.

Acadia Pharmaceuticals Inc. is seeking a unique indication for its Nuplazid, for Parkinson's psychosis, but it remains up to FDA whether that separates it enough from other antipsychotic drugs to avoid a boxed warning.

Nuplazid (pimavanserin) is a part of a new class of non-dopaminergic antipsychotic drugs that are selective serotonin inverse agonists preferentially...

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US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much

 
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Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.

New US FDA Biologics License Pathway Could Be Missing Link To Reduce Animal Testing

 

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ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
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Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

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