FDA did not not post any warning letters to Sponsors/Monitors/CROs, IRBs or Clinical Investigators this week. From the archives, here is the Inspection Summary for Topiramate ER Capsules submitted by Surpernus Pharmaceuticals, Inc. Inspections focused on both the clinical and analytical portions of these bioavailability studies. A FDA Form-483 was issued to the Phase I unit used for one of the studies.
Dedicated Phase I, Inc. was cited for failing to obtain a single pK sample from a subject at a single timepoint. In addition, FDA notes that the clinical study report submitted indicated that there were three pK samples drawn from separate subjects where the actual time of the pK draw was unknown. FDA goes on to note that Dedicated Phase I, Inc. closed following the FDA inspection.