Articles By Jof Enriquez

  1. FDA Delays Final Rule On Off-Label Promotion By One Year
    3/22/2017

    The U.S. Food and Drug Administration (FDA) is suspending the effectivity of its final rule on off-label promotion for another year.

  2. J&J CEO Pushes For Industry Innovation, Regulatory Reform Amid Healthcare Changes
    3/21/2017

    Johnson & Johnson CEO Alex Gorsky says pharmaceutical, medtech, and healthcare companies should continue to have the ability to innovate amid challenges brought about by impending changes to United States healthcare policy and legislation.

  3. MHRA Issues Pre- And Postmarket Clinical Trial Design Recommendations For Leadless Pacemakers
    3/20/2017

    The United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has released initial recommendations for pre-market and postmarket clinical evaluation of leadless cardiac pacemakers.

  4. President Trump's 2018 Budget Plan Doubles User Fees
    3/17/2017

    The Trump administration has released its budget proposal for fiscal year 2018 that will more than double the user fees collected from drug and device companies for U.S. regulatory review of medical products.

  5. Stryker, S&N Unveil Robotic-Assisted Total Knee Systems At AAOS
    3/16/2017

    Stryker and Smith & Nephew unveiled total knee applications for their respective robotic-assisted reconstructive surgery platforms this week at the 2017 Annual American Academy of Orthopaedic Surgeons (AAOS) meeting in San Diego, Calif.

  6. U.S. Senate Confirms Seema Verma As CMS Administrator As Health Reforms Loom
    3/15/2017

    The Republican-led Senate has voted 55-43 to confirm Seema Verma, President Donald Trump's nominee to head the Centers for Medicare and Medicaid Services (CMS), the federal agency that administers major healthcare programs to over 130 million Americans.

  7. Trump Picks Scott Gottlieb As Next FDA Commissioner
    3/14/2017

    President Donald Trump will nominate Scott Gottlieb, a physician and former official at the Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS), as the next FDA commissioner, replacing Robert Califf.

  8. AdvaMed Identifies The 2017 FDA Guidances With Highest Priority Among Its Members
    3/13/2017

    The medtech trade group AdvaMed (Advanced Medical Technology Association) has identified the guidance documents issued — or to-be-issued — by the U.S. Food and Drug Administration that are considered the highest priorities among its members.

  9. Protecting Implantable Medical Devices From Malware, Side-Channel Attacks
    3/10/2017

    University of Arizona researchers are trying to shore up implantable medical devices' defenses against cybersecurity threats by developing technologies to better detect malware and thwart side-channel attacks.

  10. Obamacare Replacement Will Permanently Remove Medical Device Tax
    3/9/2017

    Republican leaders in the U.S. House of Representatives have unveiled proposed legislation to repeal and replace the Affordable Care Act, which, among several tax cuts, will eliminate permanently the 2.3 percent excise tax on medical devices and products.