January/February 2013 Evolving Roles of Physicians in Drug and Device Promotion, Journal of Health Care Compliance
07/25/12 FDA User Fee Act Full of Surprises for Pharma and Biotech
FDA user fee reauthorization law expands fees to include generic and biosimilar applications, and includes a new emphasis on drug supply chain safety and incentives for development of new therapies.
02/09/12 FDA Issues Three Draft Guidances for BiosimilarsView all publications
Initial guidance provides insights on regulatory pathway for biosimilars, but does not address many critical issues.
09/06/11 Former FDA Regulatory Counsel Returns to Morgan LewisView all news
Morgan Lewis announces that Alexis Reisin Miller has returned to the firm as a partner in its FDA & Healthcare Practice, resident in Washington, D.C.