Covis Pharma GmBH – FDA EIR, Oct 22, 2018

An FDA pre-approval inspection of AMAG Pharmaceuticals, Inc., located in Waltham, MA, was conducted from October 15-22, 2018. This high-priority inspection, performed under the Bioresearch Monitoring Compliance Program Guidance Manual, focused on the company's sponsor responsibilities for clinical studies BMT-301 and BMT-302, which supported New Drug Application (NDA) 210557 for VYLEESI (bremelanotide). Although no formal inspectional observations (Form FDA 483) were issued, several significant concerns were discussed with company management. These included the failure to report the transfer of sponsor obligations to the FDA in both the Investigational New Drug (IND) and NDA submissions. The inspection also identified an unclear training plan regarding specific required modules for site staff roles, with a notable number of personnel at three out of four reviewed sites not completing essential online training. Additionally, site staff without clinical degrees were approved to conduct Hypoactive Sexual Desire Disorder (HSDD) assessments, despite the medical monitor's recommendation for such diagnosticians to possess clinical qualifications. Data integrity issues were also highlighted, as the electronic Trial Master File (eTMF) lost all associated metadata during its transfer from the contract research organization, and certain electronic approvals for critical plans were found to be non-compliant with relevant regulations. AMAG's management acknowledged all discussed observations, indicating an expectation for corrective measures.