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VALID v. VITAL: Which bill will win in the fight to reform IVD testing?

With the deadline for the reauthorization of the Medical Device User Fee Amendments (MDUFA) looming in September, many observers expect that the push for reform in the regulation of in vitro diagnostic (IVD) tests may soon be coming to a head on Capitol Hill. At its core, the debate boils down to whether regulatory oversight [...] Read More

Proposed FDA Framework for Importation Requires Cooperation from Manufacturers, Raising Questions of Impact

The Food and Drug Administration (FDA) has released their long-awaited proposed rule on prescription drug importation. President Trump has mentioned his plan at events in recent months, citing the plan as part of the administration’s efforts to lower prescription drug costs. The proposed rule outlines requirements for so-called Section 804 Importation Programs (SIPs), named after [...] Read More

Medicare Can Do More to Improve Access to Digital Health For Seniors

Smart phones, social networks and internet applications help us communicate with family, friends and colleagues, but they can do so much more to improve our lives. Advances in technology and connectivity offer new methods for monitoring and accessing information about our health and well-being. Earlier this year, CMS Administrator Seema Verma announced that the Centers [...] Read More

Council of Economic Advisers Wades into Drug Pricing Conversation

On February 9, 2018, the Council of Economic Advisers released a report looking at drug pricing proposals entitled “Reforming Biopharmaceutical Pricing at Home and Abroad.” The report highlights two goals: reducing the price that Americans pay for biopharmaceutical products and raising innovation incentives as a way to reduce the overall price of health in the […]

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