Former FDA Generics Official Joins Lachman Consultants

Former CDER Office of Generic Drugs Division of Legal and Regulatory Support deputy director Martin H. Shimer II has joined Lachman Consultants after a 22-year career at the agency. At the ANDA consulting firm, Shimer will “assist clients with regulatory submissions and strategy, communications with FDA, and navigating the approval process while offering guidance on issues related to therapeutic equivalence, patent certifications, 180-day exclusivity, the competitive generic therapy pathway, new drug application exclusivities, regulatory requirements for ANDAs and more,” the company says.

In his previous role at FDA, Shimer, who is a pharmacist, led the Patent and Exclusivity Team, implemented new statutory requirements, actively resolved complex regulatory issues related to generic applications, and helped develop the Drug Competition Action Plan, according to Lachman.