Archive for May 9th, 2016

Will FDA Changes Lead to a Better Combination Products Review System?

You need to decipher ever-complex guidelines and a labyrinth of legislation before you can get a combination product to market. Correct product labeling and training is no longer enough; your company requires comprehensive workflows to mitigate the risks involved in the manufacturing process. The FDA hopes to iron out the kinks in combination product review with a new lean management model, which was announced in March. But what does this mean if you already struggle with FDA-imposed rules and regulations? Read more »