Twelve Guidances For High-Priority FDAMA Provisions Released By CDRH
This article was originally published in The Gray Sheet
Executive Summary
Early revisions to 12 device guidance documents implementing high-priority provisions of the FDA Modernization Act likely will be made only in response to comments from manufacturers or other interested groups, agency staffers say.
You may also be interested in...
Industry Should Prefer Early Collaboration "Agreement" Meetings - Alpert
FDA's propensity to suggest that sponsors hold non-binding "agreement" meetings in lieu of binding "determination" meetings in their pursuit of agency go-ahead is in industry's best interest, Susan Alpert, director of the Center for Devices and Radiological Health's Office of Device Evaluation, maintained.
Sanofi Prepares Pulmonologists As Dupixent Nears COPD Finishing Line
The French drugmaker has identified education as a key challenge ahead of its June action date for the huge-selling IL4/IL-13 inhibitor in the lung condition. An approval would make it the first biologic for the disease.