Gottlieb Promises More Balance On Combination Product Reviews
Executive Summary
US FDA Commissioner Scott Gottlieb told a Medical Device Manufacturers Association crowd that he will try to assure more balance between device and drug regulatory leads for combination product reviews at the agency.
You may also be interested in...
FDA Combination Product Submissions May Need More Drug Info
Recent guidance document revisions mandate that combination product sponsors provide additional information on the patent and exclusivity status of any drug components. The US agency addressed the changes in a March 20 webinar.
US FDA Extends Safety-Reporting Deadline For Certain Combination Products, Issues Guidance
After issuing a major combination product post-market safety reporting rule at the end of 2016, US FDA released guidance to add context for companies developing the products. The agency has also extended compliance deadlines in many cases until 2019.
FDA Final Guidance On Drug/Device Classifications Misses The Mark, Attorneys Say
The final guidance adds some requested clarifications, but does not appear to address the US agency's tendency to designate products as drugs over devices, industry attorneys argue.