Senate committee proposes easier approval process for medical devices

The U.S. Senate Committee on Health, Education, Labor and Pensions favorably reported a measure today that would reduce regulatory hurdles for the approval of medical devices. The “FDA Device Accountability Act of 2015” (S. 1622), sponsored by Sens. Richard Burr, R-N.C.; and Al Franken, D-Minn., and co-sponsored by Mark Kirk, R-Ill., is intended to ensure the “least burdensome means” of evaluating medical devices, according to the bill’s authors. It requires that any FDA employee involved in the premarket submission process of medical devices receives training to make the approval of (Read more...)

Medical rehabilitation bill recommended in Senate

The U.S. Senate health committee today recommended legislation to strengthen and increase the visibility of medical rehabilitation research at the NIH.The “Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act” (S. 800), sponsored by Sens. Mark Kirk, R-Ill.; Michael Bennet, D-Colo.; Orrin Hatch, R-Utah; Lisa Murkowski, R-Alaska; Johnny Isakson, R-Ga.; and Susan Collins, R-Maine, calls for the development of a comprehensive research plan at the agency to support the recovery of stroke victims and help patients return to work.

Senate committee adopts bill to facilitate genetically targeted drug development

The U.S. Senate Committee on Health, Education, Labor and Pensions adopted legislation today designed to speed up development of genetically targeted drugs for patients with rare and serious or life-threating conditions.The “Advancing Targeted Therapies for Rare Diseases Act of 2015” (S. 2030), sponsored by Sens. Michael Bennet, D-Colo., Richard Burr, R-N.C., Elizabeth Warren, D-Mass., and Orrin Hatch, R-Utah, will allow drug companies seeking approval of a candidate therapy to leverage data from previously approved drug applications and to maximize the use of certain scientific methods, such as surrogate endpoints, to (Read more...)