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Cures Act: Signed into law, now comes the hard part
In a strong show of bipartisanship, Congress overwhelmingly passed the 21st Century Cures Act, which President Obama signed into law in December 2016. With promises on transforming aspects of how the FDA regulates...
Remediation from Distributor Fiasco
When your cherished distributor fails to meet sales targets, you may be inclined to end the relationship and swiftly move to a new distributer. Only if things were so simple. Tribulations related to distributor fallout...
Can Your Patients Get You to Market Faster?
Amidst the ultra-competitive medical device space, manufacturers are constantly striving to develop the newest, first-in-class and game-changing products. Without an effective strategy to register novel products, the...
Medical Device Tax: On the road to a full repeal?
The impending bill to repeal and replace the Affordable Care Act was unveiled earlier this month. As part of the bill, the controversial medical device excise tax imposed to help pay for the Affordable Care Act would...