Combo Products Office Would Mitigate Cost Bias Under User-Fee System
This article was originally published in The Gray Sheet
Executive Summary
The creation of an FDA office for combination products would leave open the possibility that a user-fee structured review system could be managed without manufacturers given the option to request a particular center based on cost considerations.
You may also be interested in...
Kramer Continues Combo Product Stewardship, Fosters Intercenter Consults
FDA Office of Combination Products Director Mark Kramer will be assisted by Suzanne O'Shea, who is leaving the Office of the Ombudsman to serve as product assignment officer
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.