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The Politics Of US FDA Advisory Committees

 
• By Michael McCaughan

FDA has a series of potentially high-profile advisory committees lined up to kick off 2022. One key underlying theme: whether and when the agency should use advisory committees to combat the perception of undue political pressure.

How might Congress influence FDA advisory committees this year? • Source: Alamy images

The US Food & Drug Administration is coming off a record low year for using its advisory committees as part of the new drug review process, but heads into 2022 with a string of potentially high-profile topics lined up for panel reviews. (Also see "US FDA Advisory Committees: Flipping FDAAA Mandate On Its Head" - Pink Sheet, 11 January, 2022.)

The meeting topics are diverse and unusual, but collectively raise an important long-term issue for FDA: when and how should...

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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

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

 
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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.

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

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

 
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EU CHMP Opinions And MAA Updates

 
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.