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Author Archives: Denise Bell

HHS/FDA ADVANCE DRUG IMPORTATION WITH PROPOSED RULE

On December 18, HHS and the FDA issued a Noticed of Proposed Rulemaking (NPRM)  that would allow states to import prescription drugs from Canada. The proposed rule follows an Administration announcement in July that HHS would be examining pathways for safe drug importation. 

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Medical Device Tax Repeal Heads to the President’s Desk

After nearly a decade-long fight, and disruptive, short-term reprieves, Congress has finally permanently repealed the medical device tax. On Tuesday. BioUtah alerted our life sciences community about a vote in the House to end the tax as part of a larger FY 2020 spending bill (repeal provision is on page 585). Yesterday, the Senate cleared […]

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Medical Device Tax to be Permanently Repealed This Week

Yesterday, top congressional leaders and the White House unveiled a $1.4 trillion FY 2020 government spending agreement that will fully repeal the 2.3% medical device tax, first enacted as part the Affordable Care Act in 2010. “This is a big win for Utah’s medical device industry and most importantly, a big win for patients whose […]

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House Passes Pelosi Drug Pricing Plan

On Thursday, the Democrat-led House passed H.R. 3, the Lower Drug Costs Now Act, by a vote of 230-192. The bill, a priority for Speaker Pelosi, mandates extensive price controls and passed largely along party lines. Only two Republicans in marginal districts voted for the legislation.

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New Analysis Concludes Pelosi’s Drug Plan would Harm Innovation

POLICY UPDATE – DRUG PRICING Concerns Expressed by Investors, Small Companies  House Speaker Nancy Pelosi’s drug pricing measure, H.R. 3 , the Elijah E. Cummings Lower Drug Prices Now Act, is coming under increasing scrutiny as concerns grow about the bill’s negative impact on innovation and future investment in smaller, emerging drug discovery companies. Yesterday, […]

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House Democrats’ Drug Pricing Bill Heads to a Floor Vote

Speaker Pelosi’s drug bill, H.R. 3, now named the Elijah E. Cummings Lower Drug Costs Now Act, after the longtime congressman who died last week, heads to the floor for a vote after being considered by three House Committees – the Energy and Commerce, Labor and Education and, Ways and Means Committees. A full House […]

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Representative Ben McAdams Visits BD

On Wednesday, October 2nd, Representative Ben McAdams visited the operations of Becton Dickinson in Sandy, Utah.  Representative McAdams was familiar with Becton Dickinson having visited previously when serving as Mayor of Salt Lake County.  Executives of Becton Dickinson including Rob Fredericks, Vice President and General Manager, Vascular Access Devices, initially met with Representative McAdams and […]

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ProLung Announces Results of New Clinical Study At Ribbon Cutting

Yesterday, ProLung welcomed Salt Lake City Mayor Jackie Biskupski, partners, dignitaries, and members of Utah’s life sciences community as the company celebrated its move to a new location with a ribbon cutting ceremony.  ProLung CEO, Jared Bauer, addressed guests, announcing that the company’s move to the Labs at Northgate coincided with good news on recent […]

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FDA Clears the Smart-C Advanced X-ray Imaging System from Turner Imaging Systems

(Orem, UT) October 2, 2019_Turner Imaging Systems, a developer of advanced x-ray imaging systems, today announced the Company has received FDA 510(k) clearance for its Smart-C Mini-C Arm Portable Fluoroscopy and X-Ray Imaging Device.  What makes this device unique is its true mobility and portability. The patent-pending Smart-C weighs only 16 pounds so that it […]

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Impeachment Could Complicate Drug Pricing Agenda

The recent launch of a House impeachment inquiry is likely to throw a wrench into efforts to reach a deal in Congress on drug pricing legislation before the end of the year. Meanwhile, President Trump is pushing his own drug pricing proposals through regulation and executive order, including tying drug prices to an international price […]

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MDMA, AdvaMed, MITA and a Broad Coalition of Stakeholders Urge Congress to Permanently Repeal the Medical Device Tax

Washington, DC – The Medical Device Manufacturers Association (MDMA), the Advanced Medical Technology Association (AdvaMed), the Medical Imaging & Technology Alliance (MITA) and a broad coalition of medical innovators, physician inventors, patient groups, and others sent a letter to congressional leadership today urging them to permanently repeal the medical device excise tax. “The United States is […]

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Product Recall Prevention and Recovery: 4 Critical Steps

15 August, 2019 by James Jardine, Staff Writer, MasterControl EDITOR’S NOTE: This is one in a series of highly popular GxP Lifeline blog posts that we are republishing in order to share their important subject matter and insights with a wider audience. If a person makes a mistake, a simple apology is often enough to fix […]

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