FDA WARNING_LETTER - Teasley, Laura A., M.D. - August 24, 2010

The FDA issued a Warning Letter to Dr. Laura A. Teasley following an investigation conducted between July 26 and August 24, 2010, regarding her conduct of clinical investigation Protocol (b)(4) for (b)(4) from March 2008 to March 2009. The inspection, part of FDA's Bioresearch Monitoring Program, found that Dr. Teasley failed to adhere to statutory requirements and FDA regulations governing clinical investigations.

Specifically, Dr. Teasley failed to personally conduct or adequately supervise the clinical investigation, violating 21 CFR 312.60. She delegated the responsibility for obtaining fundus photographs and OCT scans to a study coordinator, leading to discrepancies where baseline OCT scans and fundus photographs for subjects, including 0035 and 0015, did not match separately taken photographs of the same eyes. This raised concerns about subject eligibility and data integrity.

Additionally, Dr. Teasley failed to ensure the investigation was conducted according to the investigational plan (21 CFR 312.60). Protocol (b)(4) required central subfield thickness on OCT of ≥ 250 microns for eligibility. However, off-center OCT scans for subjects 0003 and 0040 made them appear eligible when they may not have been, undermining data reliability and integrity and raising concerns about subject safety and welfare.

Dr.