Tag Archives: Impacting

Burden of “Right to Try” Implementation on Sponsors (for Now); Risk of Unexpected SAEs Negatively Impacting Development and Approval Still Remains

By James E. Valentine & David B. Clissold — On May 30, 2018, the federal “Right to Try” law was enacted, creating a new legal framework for access to investigational drugs in limited situations outside of a clinical trial. See … Continue reading

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How the #MeToo Movement Is Impacting the American Legal Landscape

Civil Rights lawyer Gloria Allred says impact goes beyond Bill Cosby’s conviction. According to Exchange Magazine, the #MeToo hashtag has been posted more than 12 million times since January 1, 2018. The Movement has spread worldwide, to more than 70 … Continue reading

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CMS Proposes Payment and Policy Changes Impacting SNFs for FY 2019 – Plus a New “Patient-Driven Payment Model” Case Mix System for FY 2020

The Centers for Medicare & Medicaid Services (CMS) has issued its annual proposed update to Medicare skilled nursing facility (SNF) PPS rates and policies for fiscal year (FY) 2019. In addition to providing a $850 million boost to Medicare payments … Continue reading

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Recent Volcanic Eruptions at Hawaii’s Kilauea Impacting Cruise Ship Visits?

Photo Credit: USGS Volcanic eruptions Kilauea, the most active volcano on Hawaii’s Big Island, have done little to stop cruise ships from making scheduled stops. Apparently, the lovely islands of Hawaii are “open for business.” Per a May 8 (and … Continue reading

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Other Aspects Of The 2017 Tax Cuts And Jobs Act Impacting Business Aviation

In addition to clarifying the exemption of aircraft management services from FET (which I discussed in my February 9, 2018 post), the 2017 Tax Cuts and Jobs Act (the "Act") also included several other provisions with a direct impact on … Continue reading

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