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FDA's Combo Product Consultations To Be Streamlined

 
• By David Filmore

Internal assessment finds inter-center collaboration stymied by issues ranging from IT compatibility to resource reimbursement, but FDA says it has a five-point plan to improve the process.

An internal assessment of FDA's inter-center consultations for combination products has found the process overly cumbersome, but FDA says it is already simplifying access to its IT system, revising instruction manuals, updating its organizational charts and putting out more guidance documents to address the concerns raised in the report.

The assessment, conducted by the agency's Office of Planning, was launched in 2014 in response to complaints from industry that...

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More from North America

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• By Derrick Gingery

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

Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
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Payment Cap Not Always Solution For Unaffordable Drugs, Maryland PDAB Director Says

 
• By Cathy Kelly

The state's Prescription Drug Affordability Board, the oldest of a growing list of the boards, chose six drugs for affordability reviews and has the authority to set a ceiling on the amount state and local government payers would reimburse for them.