Keeping Track: US FDA, Industry Roar Into Fourth Quarter With Bevy Of Regulatory Announcements
The latest drug development news and highlights from our US FDA Performance Tracker.
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Pediatric Data Planning Should Start While Adult Drug Development Is In Its Infancy
Innovative trial designs and biostatistics can make pediatric drug development more efficient, but strategies like extrapolating adult data using bridging biomarkers or Bayesian analyses have complex data requirements that demand coordination and forethought.
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.
As US FDA Settles Into Teleworking, Will Application Reviews Be Affected?
Productivity may suffer under coronavirus-mandated telework despite workforce diligence, experts say.