As combination products continue to increase in number and complexity, FDA has shifted its focus to developing more effective ways to review them. While FDA has strived to clarify regulatory requirements and coordinate product reviews among the various centers, it is often difficult to know how a product will be classified and, as a result, what center will be tasked with reviewing its application.
On December 17, 2015, the Food and Drug LawInstitute (“FDLI”) will hold a workshop in Washington, D.C., titled “Combination Products Workshop – A Comprehensive Overview,” that is intended to provide a comprehensive look at how FDA makes its jurisdictional decisions, how a company can file a persuasive, accurate Request for Designation, and how to understand and fulfill the manufacturing practices required. Hyman, Phelps & McNamara, P.C.’s Jeffrey K. Shapiro will participate on a panel at the workshop focusing on streamlined cGMP requirements, including the draft guidance issued earlier this year.
A copy of the FDLI workshop agenda and information on registration is available here. FDA Law Blog readers can get a 15% discount by using speaker referral code COMBO15.