Martin H. Shimer, II, RPh
Martin H. Shimer is an Executive Director at Lachman Consultants with over 20 years of experience at the US FDA. While Deputy Director of the Division of Legal and Regulatory Support at the FDA, Mr. Shimer was responsible for implementation of new statutory requirements and resolving complex issues (legal, scientific and/or regulatory) impacting ANDAs. He has extensive experience in ANDA review for regulatory and legal compliance. Mr. Shimer was a negotiator for the GDUFA II program and has conducted presentations on various aspects of the generic program for other governmental agencies, DIA, AAM, Congressional staff and many divisions with FDA. He has also received multiple commendations for his work with the FDA, including the Commissioner’s Special Citation, numerous other FDA Recognition Awards and the FDLI Distinguished Service and Leadership Award.