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U.S. Senate

Xavier Becerra confirmed as HHS secretary

March 18, 2021 By Sean Whooley

The U.S. Senate narrowly voted to confirm Xavier Becerra as the U.S. Dept. of Health & Human Services (HHS) secretary today. Becerra received the nomination for the position from President Joe Biden in December 2020. Today, the Senate voted 50-49 in favor of Becerra, who will have to resign his seat as California’s attorney general. […]

Filed Under: Business/Financial News, Featured, Healthcare Reform, Medicare, Regulatory/Compliance Tagged With: coronavirus, COVID-19, Dept. of Health & Human Services (HHS), HHS, Joe Biden, U.S. Senate

U.S. should have enough COVID-19 vaccine by Q3 2021, CDC head tells Senate panel

September 16, 2020 By Nancy Crotti

CDC director Dr. Robert Redfield told a Senate panel today that the federal government should have enough coronavirus vaccine for Americans to resume “regular life” by the third quarter of 2021, according to a report by CNBC. Redfield said vaccinations could begin November or December of 2020 and that it could take 6 to 9 months to […]

Filed Under: Distribution, Drug-Device Combinations, Featured Tagged With: coronavirus, COVID-19, U.S. Centers for Disease Control and Prevention, U.S. Senate, vaccines

New bill would provide $75B for PPE, ventilator production

May 4, 2020 By Nancy Crotti

A bill by two progressive Congressional Democrats would provide the federal government with $75 billion to produce or purchase personal protective equipment (PPE) and medical devices to fight the COVID-19 pandemic. Sen. Bernie Sanders (I-Vt.) and Rep. Ro Khanna (D-Calif.) are co-sponsoring the bill, which aims to provide the money to the Federal Emergency Management […]

Filed Under: Business/Financial News, Featured, Hospital Care Tagged With: coronavirus, COVID-19, U.S. House of Representatives, U.S. Senate

Senate Dems propose federalizing medical supply chain

April 29, 2020 By Nancy Crotti

Senate Democrats today introduced a bill that would put control of the nation’s medical supply chain in the hands of the federal government, using its expertise in military production and distribution to address the COVID-19 pandemic. The Medical Supply Delivery and Transparency Act would require the secretary of defense to appoint a civilian with experience […]

Filed Under: Business/Financial News, Distribution, Featured, Hospital Care, Lab Instruments & Supplies, Regulatory/Compliance Tagged With: COVID-19, supply chain, U, U.S. House of Representatives, U.S. Senate

Senate committee favors Hahn for FDA chief

December 3, 2019 By Nancy Crotti

A Senate panel has recommended approval of Dr. Stephen Hahn as the new commissioner of the FDA. The U.S. Senate Committee on Health, Education, Labor & Pensions voted 18 to 5 to approve the nomination of Hahn, the chief medical officer at Houston’s M.D. Anderson Cancer Center. Hahn would replace acting commissioner Dr. Brett Giroir, […]

Filed Under: Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: FDA, Stephen Hahn, U.S. Senate

Senators question proposed device approval changes

July 5, 2019 By Nancy Crotti

U.S. Senators Patti Murray (D-Wash.) and Elizabeth Warren (D-Mass.) are challenging an FDA budget proposal that would ease the approval process for certain medical devices. In a June 24 letter to Acting Commissioner Dr. Ned Sharpless and Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health, Murray and Warren target the “progressive […]

Filed Under: Featured, Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: FDA, U.S. Senate

Medtronic: Infuse data delay was inadvertent

May 19, 2016 By Brad Perriello

Medtronic (NYSE:MDT) reportedly said this week that its years-long delay in releasing adverse event data for its controversial Infuse bone-growth protein was inadvertent. The Minneapolis Star Tribune last month reported that a 2-year Medtronic review of some 3,647 Infuse patients in 2008 turned up about 1,000 adverse events that weren’t reported to the FDA until 2013. That prompted Sens. Al Franken […]

Filed Under: Clinical Trials, Orthopedics, Regenerative Medicine, Spine Tagged With: Capitol Hill, Medtronic, U.S. Senate

Senate bill would streamline FDA’s medical device reviews

March 21, 2016 By Brad Perriello

A bipartisan duo in the U.S. Senate introduced a bill last week that aims to streamline the way the FDA reviews medical devices. Sens. Amy Klobuchar (D-Minn.) and Pat Roberts (R-Kan.) introduced S.2737, or “A bill to improve medical device innovation,” to the Upper Chamber’s Health, Education, Labor & Pensions committee March 17. Earlier this month the panel […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Senate Health Education Labor & Pensions committee, U.S. Senate

Senators Warren, Grassley want more from CMS on UDIs

March 15, 2016 By Fink Densford

U.S. Senators Chuck Grassley of Iowa and Elizabeth Warren of Massachusetts are pushing for more unique device identifier integration on medical claim forms from U.S. healthcare agencies, with a focus on the Centers for Medicare and Medicaid Services. CMS was called out for expressing views on the system that are contradictory to those from the Department of […]

Filed Under: Business/Financial News, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Centers for Medicare and Medicaid Services (CMS), FDA, U.S. Department of Health, U.S. Senate

Senate panel advances FDA fast-track bill

March 10, 2016 By Brad Perriello

A U.S. Senate panel yesterday advanced a bill that would create a fast-track program at the FDA for breakthrough medical devices. The Senate Health, Education, Labor & Pensions committee sent the bill, S. 1077 or “A bill to provide for expedited development of and priority review for breakthrough devices,” to the Senate floor. The bill, introduced last […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Capitol Hill, Senate Health Education Labor & Pensions committee, U.S. Senate

US Senators urge FTC to probe Baxter, Braun & Hospira saline prices

October 27, 2015 By Fink Densford

Four U.S. Senators yesterday wrote the FTC urging a probe into possible illegal saline price inflation of 200-300% since a shortage of the fluid began in late 2013. The letter, sent to FTC chairwoman Edith Ramirez, was signed by Conn. dem senator Richard Blumenthal, Minn. dem Amy Klobuchar and Utah reps. Mike Lee and Orrin […]

Filed Under: Business/Financial News, Legal News Tagged With: B. Braun, Baxter, Federal Trade Commission (FTC), Hospira Inc., U.S. Senate

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