Bradley Merrill Thompson, Leah Kendall: Article on Top Ten FDA Development Issues for 2011Drug Development & Delivery March 15, 2011
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office and Leah Kendall, an Associate in the Health Care and Life Sciences practice, in the Washington, DC, office, cowrote an article titled "FDA Regulatory Update: Top 10 Policy Development Issues for 2011 & What May Stand in the Way of Advancing Them."
Here is an excerpt:
The FDA' Office of Combination Products (OCP) has for many years engaged on policy issues and how best to serve patient needs with respect to drug delivery and other combination products in a thoughtful and patient-focused manner. However, it seems that in recent years, the significant increases in the OCP's workload have created a need for additional resources specifically devoted to supporting the OCP and combination product policy development, while at the same time preserving the OCP's other functions, including the informal dialogue in which the OCP engages with industry and the public. This discussion will summarize that resource quandary, and then will turn to highlighting the top 10 policy issues percolating in the drug delivery and combination product area.