Day: May 12, 2016

Last December, we discussed how the snack bar company, Kind LLC, was first slammed by FDA for using “healthy” on its label and its fight to convince FDA to use current nutritional standards. This week, FDA reversed its decision and allowed the company to use “healthy” label on its packaging in relation to its “corporate philosophy,” not as a … Read more

Over the last few years, FDA has implemented several new pathways to expedite patient access to new drugs, biologics and medical devices. These programs, such as breakthrough designation, Fast Track review, Expedited Access Pathway and Priority Review, have significantly reduced the development and review time for new products. Faster approval adds more pressure on FDA to conduct … Read more