Search Results for Elizabeth Warren

Showing 1 – 8

Markey and Warren Re-Intro Bill to Repeal Medical Device Tax By Zachary Brennan - Published 15 January 2018

Sens. Ed Markey (D-MA) and Elizabeth Warren (D-MA) re-introduced a bill from 2015 last week that would permanently repeal a 2.3% medical device tax that was delayed for two years but took effect at the beginning of this year.

Categories: News, US, Government affairs, Medical Devices

Tags: Elizabeth Warren, medical device tax

HHS Secretary Nominee Azar: Top Priority is Drug Prices By Zachary Brennan - Published 29 November 2017

The Senate Health, Education, Labor and Pensions Committee hearing on Wednesday grilled President Donald Trump's HHS secretary nominee and former Eli Lilly executive Alex Azar on drug prices, and he vowed that the issue would be his top priority.

Categories: News, US, Drugs, Government affairs, Regulatory intelligence

Tags: HHS Secretary, Rand Paul, Elizabeth Warren, drug prices

Sen. Warren: Adding UDIs to Medicare Claims Forms Should be a 'No-Brainer' By Zachary Brennan - Published 01 November 2017

Millions of Americans are implanted with various medical devices each year, though the Centers for Medicare & Medicaid Services (CMS) still lacks the ability to track which devices prematurely fail or are recalled based on claims data.

Categories: News, US, FDA, Government affairs, Medical Devices, Postmarket surveillance

Tags: Elizabeth Warren, unique device identifiers, Medicare claims forms

Senate Democrats to Trump: Work With us to Lower Drug Prices By Zachary Brennan - Published 20 December 2016

Sens. Sherrod Brown (D-OH), Al Franken (D-MN) and 17 of their Democratic and Independent colleagues on Tuesday sent a letter to President-elect Donald Trump, urging him to combat the pharmaceutical industry’s “abusive tactics” that “price lifesaving drugs out of reach for those in need.”

Categories: News, US, Drugs, Reimbursement

Tags: Franken, Elizabeth Warren, Trump, CMS, drug prices

Grassley and Warren Call for UDIs to be Added to Health Insurance Claims Forms By Zachary Brennan - Published 31 August 2016

Incorporating unique device identifiers (UDIs) into health insurance claims forms could help improve the postmarket tracking of medical device safety concerns and performance, Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) wrote in a letter earlier this week to the chair of an Accredited Standards Committee.

Categories: News, US, FDA, Labeling, Medical Devices

Tags: Chuck Grassley, Elizabeth Warren, UDI, health insurance claims forms

Senators Grill CMS on Incorporating UDIs Into Insurance Claims Forms By Michael Mezher - Published 09 March 2016

Senators Elizabeth Warren (D-MA) and Charles Grassley (R-IA) questioned the Centers for Medicare and Medicaid Services' (CMS) opposition to incorporating the unique device identifier (UDI) for medical devices into insurance claims forms.

Categories: News, US, FDA, Medical Devices, Postmarket surveillance

Tags: UDI, Unique Device Identifier, Sen. Elizabeth Warren (D-MA), Sen. Charles Grassley (R-IA), CMS, Centers for Medicare and Medicaid Services

Senators Hint at Confirmation of Califf as Next FDA Commissioner By Zachary Brennan - Published 17 November 2015

Senators on both sides of the aisle offered their support for Robert Califf to be the next commissioner of the US Food and Drug Administration (FDA) at the confirmation hearing Tuesday despite a couple of heated questions on drug pricing and industry’s influence on him.

Categories: News, US, FDA, Biologics and biotechnology, Blood, Clinical, Combination products, Drugs, Government affairs, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance, Preclinical, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Califf, Senate HELP, FDA commissioner, Senate confirmation hearing, Duke University, Margaret Hamburg, Elizabeth Warren, Bernie Sanders

Senator Wants Companies Who Break FDA Regulations to Help Fund NIH By Alexander Gaffney, RAC - Published 23 January 2015

US Sen. Elizabeth Warren (D-MA) has unveiled plans to introduce new legislation she says will require pharmaceutical companies found guilty of regulatory and legal non-compliance to pay large fines, all in the hopes of providing a new funding stream to the National Institutes of Health (NIH).

Categories: News, US, FDA, Advertising and Promotion, Biologics and biotechnology, Compliance, Drugs, Ethics

Tags: Elizabeth Warren, NIH, National Institutes of Health, Regulatory Noncompliance, Swear Jar, Congress, Senate, Legislation, Medical Innovation Act