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The budget request includes $100 million to advance the use of real-world experience to develop clinical data to expedite medical product development. Read More
The program aims to validate how a pharmaceutical version of Dronabinol, an FDA-approved cannabinoid being developed by Insys, can be delivered through Senzer’s inhaler device. Read More
The FDA issued Boca Raton, Florida based medical devicemaker Lexington International a Form 483 for conducting laser radiation safety testing and distributing a medical device without recording the laser output measurements. Read More
A Cleveland, Ohio medical device manufacturer drew a Form 483 after the FDA’s January inspection found the firm’s procedures were inadequate. Read More