FDA Combo Product Final Rule Adds "Intended" Use To Primary Mode Of Action Definition
This article was originally published in The Pink Sheet Daily
Executive Summary
Final rule includes an algorithm for the Office of Combination Products to use if primary mode of action cannot be established.
You may also be interested in...
Combo Product Industry Coalition Proposal Elevates Post-Approval Issues
Genzyme, Roche, Guidant are among the firms represented by the Combination Product Coalition to focus on improving post-approval regulatory pathways, such as modifications and cross-labeling for “virtual” combo products.
“Primary Mode Of Action” Reg To Facilitate Review Center Assignment Of Combo Products
FDA’s proposed rule defines primary mode as “the single mode of action of a combination product that provides the most important therapeutic action of the combination product.”
FDA Eyes Upclassification, Labeling Guidance To Address Stapler Risks
The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.