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Virtual Advisory Committees Pose Technical And Practical Challenges For US FDA, Sponsors

 
• By Sue Sutter

Recent panel review of biologics center's intramural research programs had its share of technical glitches and involved agency speakers blindly presenting to committee members they could not see; the experience suggests the difficulties an industry sponsor with an application hanging in the balance may face if a virtual advisory committee were to be held.

retro television test pattern with please stand by technical difficulties warning
Technical issues at a recent virtual AdComm included problems with audio quality and slide presentations. • Source: Shutterstock

The Center for Biologics Evaluation and Research’s recent advisory committee on intramural research programs highlights the rather significant challenges facing sponsors and the US Food and Drug Administration if and when the agency decides to conduct an entirely virtual, application-specific AdComm.

The 8 May session of the Cellular, Tissue and Gene Therapies Advisory Committee, which lasted a little over two hours, had its share of technical glitches, including panelists who could not hear the presentations or see the slides,

To be fair, the glitches were no different than those encountered by people all over the US – and much of the world – since the COVID-19 pandemic as travel restrictions and social distancing requirements have forced

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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.

More from Regulatory Trackers

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.

Global Pharma Guidance Tracker - March 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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.