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US FDA Exploring Virtual Advisory Cmtes.; Might Sponsors Want To Wait For In-Person Meetings?

 
• By Derrick Gingery

Likelihood of webcast-only advisory committee meetings may depend on the extent of the coronavirus outbreak, Office of New Drugs Director Peter Stein tells the Pink Sheet in an interview.

FDA Advisory Committee Feature image
The FDA may have to conduct virtual advisory committee meetings for some applications should coronavirus restrictions on public gatherings continue. • Source: Illustration

Sponsors moving applications through the US Food and Drug Administration assessment process should not assume that advisory committee meetings are off the table while the coronavirus is preventing public gatherings.

Office of New Drugs Director Peter Stein said in an interview with the Pink Sheet that the agency can conduct...

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America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

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

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

 
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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.

More from Regulatory Trackers

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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.

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