Cole Werble
Sanofi-Aventis dodged a number of bullets during the prolonged post-marketing review of telithromycin ( Ketek) under the watchful eye of Capitol Hill.
Data Integrity Delays: Another Key Takeaway from Ketek
Senator Grassley wants FDA to withhold NDAs from advisory committees if there are pending questions about the authenticity of any of the clinical data. The agency appears to agree. That could represent another roadblock to NDA reviews.