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Patient-Focused Drug Development, Complex Trial Design May Not Get More Funding In PDUFA VII

 
• By Derrick Gingery

US FDA proposed increasing staffing and resources for both programs during the next user fee program cycle, but industry representatives did not believe it necessary.

Clinical Trial
Changes to the FDA's Complex Innovative trial Design (CID) program may be coming in PDUFA VII. • Source: Shutterstock

Drug sponsors balked at increasing user fee funding for the Patient-Focused Drug Development and Complex Innovative trial Design programs, questioning the additional staff proposed to maintain and expand them.

Members of the prescription drug user fee reauthorization negotiating teams are finalizing language for the commitment letter that would extend...

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Only One ANDA Was Submitted To The US FDA During The Shutdown; It Should Have Been None

 
• By Derrick Gingery

The FDA told the Pink Sheet an ANDA managed to be submitted during a period when no new ANDAs could be accepted.

Obscure User Fee Provision Gives Generic Drug Sponsors More Time To Pay Fees Post-Shutdown

 
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ANDA sponsors received 20 days to pay fees associated with applications submitted during the government shutdown, while NDA and BLA sponsors only received five days.

GDUFA IV: US FDA Wants to ‘Streamline’ Formal Meeting Structure

 
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The FDA proposed changes to the formal meeting system for sponsors in the next generic drug user fee program cycle, in part to speed timelines.

Onshoring Incentives Among US FDA’s GDUFA IV Proposals

 
• By Derrick Gingery

During the first GDUFA IV negotiation session, industry representatives were unsure whether the FDA’s idea to create pathways for onshoring incentives fit the scope of the generic drug user fee program.

More from Pathways & Standards

GDUFA IV: US FDA Wants to ‘Streamline’ Formal Meeting Structure

 
• By Derrick Gingery

The FDA proposed changes to the formal meeting system for sponsors in the next generic drug user fee program cycle, in part to speed timelines.

Onshoring Incentives Among US FDA’s GDUFA IV Proposals

 
• By Derrick Gingery

During the first GDUFA IV negotiation session, industry representatives were unsure whether the FDA’s idea to create pathways for onshoring incentives fit the scope of the generic drug user fee program.

Eight African Agencies Finalizing Reliance Mechanism To Speed Drug Approvals

 
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