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

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Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.
The US FDA is receiving more requests for regenerative medicine advanced therapy designation and granting more of them, according to recently reported agency data.
More from Regulatory Trackers
March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
The European Medicines Agency is set to issue opinions this week on whether pan-EU marketing approval should be granted to a number of new products.
The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.