FDA Extends Exclusivity for Certain Combo-Meds

What’s two extra years of exclusivity worth? Enough to spark a legal fight. The FDA posted new guidance on its website Friday, awarding certain combo meds 5 years of exclusivity compared with the previous three. Drugmakers had lobbied for the change, but the timing–and the wording–are bound to be controversial.


Confusion still surrounds Sunshine Act site ahead of launch

With just a week to go before the expected release of pharma and med tech companies’ payments to physicians under the Sunshine Act, stakeholders are still in the dark about what the website will look like. The medical device industry association has long been lobbying the federal Center for Medicare & Medicaid Services to provide…

Obamacare Chart

Silicon Valley struggles to speak FDA’s language

BY MATTHEW PERRONE AP Health Writer WASHINGTON — From Apple’s new smartwatch that tracks heartbeats to contact lenses that measure blood sugar — Silicon Valley is pouring billions into gadgets and apps designed to transform health care. But the tech giants that have famously disrupted so many industries are now facing their own unexpected disruption: regulation.

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