IDE policy allowing clinical study extensions implemented across ODE.
This article was originally published in The Gray Sheet
IDE SUPPLEMENTS FOR CLINICAL STUDY EXTENSION UNTIL PRODUCT APPROVAL are being considered uniformly across all divisions of FDA's Office of Device Evaluation through a recent memo sent by ODE Director Susan Alpert to reviewers. The memo provides general principles that should be used in determining whether to follow ODE's general policy of allowing continued availability of investigational devices between completion of a clinical study and product clearance. Alpert issued the memo because some ODE divisions were not implementing the policy out of concern that devices they review require longer follow-up times to demonstrate safety and effectiveness and therefore should not get expanded protocols.
You may also be interested in...
Business development leaders and venture capital investors spoke at Biocom’s annual partnering conference about what they are seeking in relationships with entrepreneurs and start-ups.
Mylan’s full year 2019 earnings report was its last as an independent company, so the focus was on the coming merger with Pfizer’s Upjohn and growth prospects for the new company, Viatris.
Colgate Zero toothpastes and mouthwashes promote what’s missing; Tom’s of Maine natural personal care expands with prebiotic toothpaste, deodorant and hand soap; Gaia adds hemp to its herbs; and Church & Dwight goes environmentally friendly with VitaFusion Goodness supplements, adds CBD versions to line, too.