Mintz Levin Cohn Ferris Glovsky and Popeo PC
Benjamin provides counsel on compliance and regulatory issues to clients in the pharmaceutical, medical device, and biotech industries. With a clear focus on FDA regulatory counseling, Benjamin advises a wide range of life sciences and health care industry clients on the federal and state laws governing product development, clinical studies, pre-market review, promotion, and post-market compliance. His practice also includes advising clients on research approval, product labeling, and negotiating contractual relationships.
Benjamin has experience representing medical device companies at all stages of development. He develops pre-market regulatory strategies based on the proposed product and indication for use and has provided advice on 510(k) applications, de novo reclassification requests, and PMAs. Benjamin assists with pre-submission meetings and other in-person interactions with FDA. He also has substantial experience helping medical device manufacturers respond to unfavorable inspectional observations or Warning Letters and provides guidance on responding to FDA correspondence, developing comprehensive corrective action plans, and implementing corrective actions to address regulatory compliance issues.
In his practice, Benjamin also participates in the coordination of regulatory due diligence reviews of transactions involving large pharmaceutical and medical device manufacturers. He is well versed in the process of developing regulatory policy positions and submitting comments to the FDA, as well as analyzing and drafting pre-market submissions to the FDA. Benjamin drafts and negotiates clinical study agreements for clients and analyzes both clinical study and human factors protocols with respect to legal requirements.
Monday, September 23
10:30 AM – 12:00 PM