MASSDEVICE ON CALL — Rep. Ed Markey (D-Mass.) launched a new bill aimed at strengthening the FDA’s oversight of medical devices.
The Safety of Untested & New Devices Act would give the FDA the power to request that companies submitting new devices speak for any recalls or safety issues in predicate devices.
Markey hopes to add his measure to a larger medical device bill that Congress will vote on at the end of May, Boston.com reported.
Markey announced the bill at a press conference highlighting the recent clamor surrounding transvaginal mesh products and their potential dangers for women.
Former CMS chief Berwick joins the Center for American Progress
Former Centers for Medicare & Medicaid head Donald Berwick says "it’s game time" on health reform, a measure he’ll be watching closely from his new seat as a senior fellow for the Center for American Progress, the Washington Post reported.
Dems confident on health law as Supreme Court arguments near
House Minority Leader Nancy Pelosi called the Obama administration’s landmark health care reform measure "ironclad," as the bill prepares heads to the Supreme Court for opening arguments Monday, Healthwatch reported.
Biotech groups lauds Senate’s IPO act
The Biotechnology Industry Organization lauded the Senate on the passage of the "IPO On Ramp," a measure ease the regulatory requirements for IPOs and temporarily reduce the reporting burdens imposed by the Sarbanes-Oxley Act, according to a press release.
