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Oncology Pilot To Highlight Disagreements Between US FDA And Sponsor For Advisory Committees

 
• By Kate Rawson

'Point/Counterpoint' program grew out of Assessment Aid initiative in the Oncology Center of Excellence and will be unveiled at an upcoming ODAC meeting.

Large Battle Between Medieval Warriors. Medieval Reenactment. - Image
Hopefully the disagreements between the US FDA and oncology sponsors will be less pointed than this depiction.

The US Food & Drug Administration’s Oncology Center of Excellence is preparing an alternative approach to briefing documents for an upcoming advisory committee meeting intended to highlight key points of disagreement between the agency and the sponsor.

OCE Director Richard Pazdur announced the pilot almost offhand during remarks to the Friends of Cancer Research annual meeting on 12 November. At the time, Pazdur was providing an update on the OCE’s most recently unveiled pilot, the “Project Orbis” joint review program

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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

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