FDA WARNING_LETTER - Snow, Lamar L. M.D. - May 07, 2009

The FDA issued a Warning Letter to Dr. L. Lamar Snow following an inspection from April 27 to May 7, 2009, regarding his conduct of clinical investigations for ibuprofen (Amelior) in Protocol 008, Parts A and B, for Cumberland Pharmaceuticals. The inspection, part of the Bioresearch Monitoring Program, revealed that Dr. Snow failed to adhere to statutory requirements and FDA regulations governing clinical investigations.

Key violations include: 1. **Failure to Personally Conduct or Supervise (21 CFR 312.60):** Dr. Snow did not adequately supervise delegated study tasks, leading to significant problems in study conduct and compromising subject rights, safety, and welfare. 2. **Failure to Maintain Adequate and Accurate Case Histories (21 CFR 312.62(b)):** Numerous discrepancies were found between hospital records and Case Report Forms (CRFs) regarding total morphine doses administered (e.g., Subject 3255, 7060, 6057, 8058), study drug administration times (Subject 2256), and concomitant medication administration times (Subject 5059). 3. **Failure to Conduct Investigation According to Investigational Plan (21 CFR 312.60):** * Adverse events were not reported on CRFs (e.g., Subject 1