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.
11/19/13 Pharmacists, Attorneys Question Whether Drug Compounding Bill Would Improve Safety, BNA's Daily Report for Executives
Although the drug industry generally supports the bill passed by the Senate Nov. 18, attorneys and some pharmacists question whether the bill really would improve the safety of compounded drugs.
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.