FDA's Combo Products Review Transformation Begins
Executive Summary
Pilot project sets timelines for lead and consulting centers that will feed into more substantial changes in PDUFA VI.
You may also be interested in...
FDA Tussles With Combination Products, Fires Up Oncology Center Of Excellence
FDA officials discuss difficulties dealing with complex combination products, the future of the agency's Centers, and promotion of industry collaboration at DIA meeting.
FDA's Pazdur To Retain Drug Approval Duties In Oncology Center Of Excellence
Center for Drug Evaluation and Research's long-time director of oncology/hematology products office will continue as signatory on drug reviews even after new Cancer Moonshot-driven structure takes effect.
EpiPen Outrage In Congress Puts Spotlight On FDA Generic Review
House and Senate letters ask why Mylan's autoinjector doesn't have competition, offering a preview of potential debates on renewal of the generic user fee program.