Frank R. Fazzari

Frank R. Fazzari, Senior Vice President - Drugs, has been with Phoenix^SM since 1998 and has extensive experience in performing domestic and international Mock FDA PAI CGMP audits and training, writing SOPs, determining the regulatory status of drugs, resolving drug regulatory matters; and reviewing, evaluating and preparing CMC sections for IND/NDA/ANDA/DMF submissions. He has successfully assisted firms with the preparation of responses to FDA Form 483s, Warning Letters and enforcement actions. Mr. Fazzari has prepared major domestic and foreign producers of finished drugs, APIs and key intermediates to successfully pass FDA PAI inspections, and provided solutions to manufacturing control and analytical issues. He spent nearly 40 years with the FDA prior to joining Phoenix. As Assistant Director, Case Management/Acting Team Leader for New Drug Strategy at FDA, he directed the development of regulatory initiatives relating to new drug and CGMP issues. Other positions included Chief, Prescription Drug Compliance, Supervisory Research Chemist, and analytical chemist/investigator in the Detroit District. Mr. Fazzari also served on FDA committees drafting CDER Guidance documents.