During his November 17th conformation hearing at the Senate Health, Education, Labor and Pensions Committee FDA commissioner nominee Robert Califf indicated that the FDA could have a new combination pathway ready for approval within a year. He is trying to replace Margaret Hamburg, who left the FDA back in April.
During the hearing Califf agreed that the FDA’s existing structure for reviewing combination products is not suitable. “It’s a strong view at the FDA that we need another pathway that will give the FDA the flexibility to require the data that’s needed to ensure the public the proposed treatment is safe and effective.
Topics: Combination Products, FDA, Robert Califf, Product Pathway
regulations along with the communication challenges between the product centers that lead to inefficiencies. FDA officials are signaling that the combination products review process is ready for reform and the 2017 user fee authorizations offer a good opportunity to make much needed changes.
