While the notion of a medical device single review program is still more aspirational than respirational, a number of nations are shifting incrementally toward mutual recognition for medical devices.
Less than a month after disclosing that its confirmatory phase III trial of Relyvrio (sodium phenylbutyrate plus taurursodiol) fell short of its endpoint, Amylyx Pharmaceuticals Inc. is withdrawing the amyotrophic lateral sclerosis (ALS) drug from the market.
The U.S. FDA’s Jan. 5 approval of Florida’s plan to import prescription drugs from Canada to take advantage of their lower price triggered ongoing communication between senior U.S. officials and Canada’s Ministry of Health over Canadian concerns about maintaining sufficient drug supplies.