Edward John Allera
Edward John Allera focuses his practice on the development of new products and business opportunities in the areas of pharmaceuticals and technology, especially regarding the regulation and promotion of drugs, biologics and devices. Ed is a managing shareholder of the Washington, D.C., office of Buchanan Ingersoll & Rooney PC, as well as chairman of the firm’s FDA/Biotechnology Section.
He began his career at the Food and Drug Administration (FDA), where he served as associate chief counsel. As a pharmacist, one of Ed’s strengths is the ability to integrate science into the law to combat ill-considered FDA actions. He also has a cadre of experts with whom he works that enables him to create rapid, sophisticated legal/scientific rebuttals to FDA actions. He has worked extensively in the product life cycle management area and with almost every dosage form. Because he has a background in the science surrounding dosage forms and harmacokinetics, he has filed a large number of Citizen Petitions in the product life cycle management process.