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Home » Topics » Regulatory

Regulatory
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U.S. flag on columned building

Premier recommends device, drug makers be included in OIG’s anti-kickback draft

Dec. 23, 2019
By Mark McCarty
The exclusion of makers of devices and drugs from a proposed overhaul of the Anti-Kickback Statute (AKS) probably took many in industry by surprise, but Premier Inc., of Charlotte, N.C., argued that this approach fails to capitalize on an opportunity to hold manufacturers accountable for clinical outcomes in value-based arrangements.
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Regulatory front for Dec. 23, 2019

Dec. 23, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Australia unveils new companion diagnostics regulatory framework

Dec. 23, 2019
By Tamra Sami
Following lengthy consultations with industry, Australia’s Therapeutic Goods Administration (TGA) has released its new regulatory framework for in vitro companion diagnostics (IVD CDx) that becomes effective in February. Until now, Australia did not have a framework for CDx.
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Globe showing Australia

Australia unveils new companion diagnostics regulatory framework

Dec. 23, 2019
By Tamra Sami
Following lengthy consultations with industry, Australia’s Therapeutic Goods Administration (TGA) has released its new regulatory framework for in vitro companion diagnostics (IVD CDx) that becomes effective in February.
Read More
U.S. White House

Device tax falls as Trump signs FY 2020 spending bills

Dec. 23, 2019
By Mark McCarty
The much-maligned medical device tax was finally laid to rest Dec. 20, as President Donald Trump signed a spending bill that included a permanent repeal of the tax. The 2.3% excise tax on devices was brought into the statute via the Affordable Care Act (ACA), and its repeal brings much-needed breathing room to small device makers.
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FDA approves Enhertu for unresectable or metastatic HER2-positive breast cancer

Dec. 23, 2019

Orkedia approved in Japan for hypercalcemia in parathyroid carcinoma or primary hyperparathyroidism

Dec. 23, 2019

FDA approves Dayvigo for insomnia

Dec. 23, 2019

Ryaltris receives marketing approval in Australia

Dec. 23, 2019

Regulatory front for Dec. 20, 2019

Dec. 20, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
Read More
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