FDA IND Submissions, Novella Clinical

What You Need to Know About Submitting an IND to the FDA

As the nation’s principal authority overseeing the safety of food, drugs and cosmetics, the US Food and Drug Administration (FDA) requires manufacturers to provide proof of the safety and efficacy of their drugs before bringing them to market. This has … Read More

Cures Act

21st Century Cures Act Spurs Medical Device Opportunities

The 21st Century Cures Act (the Cures Act) includes many significant changes to the regulatory landscape for medical devices. Signed into law by former President Barack Obama on December 13, 2016, with overwhelming support in the House (392-26) and Senate … Read More