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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Warning letter is first issued by US FDA’s Office of Prescription Drug Promotion in more than a year and only the seventh since March 2020, continuing a trend away from using the enforcement tool. AstraZeneca asked to distribute corrective communications about pamphlet’s efficacy claims.
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.
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.