Always meticulously prepared and quick on his feet, Peter Mathers has relished in the privilege of helping clients understand and negotiate their way through complex and unprecedented regulatory issues for over 40 years. As Peter would say, I believe that regulatory practice ideally involves the balancing of opportunities and risks in light of applicable legal standards as well as the policies and practicalities, both industrial and bureaucratic, that underlie those standards.

Peter was key to litigating generic drug approval procedures with the FDA before the Hatch-Waxman Amendments were in place and has continued to be responsible for the ongoing interpretation, application, negotiation and litigation of the critical issues arising under those Amendments.