Combination Products Added to FDA’s 2016 Guidance Lineup

The FDA says it will provide advice on comparative analyses for drug-device combination generic products before the end of 2016.

The guidance added to the FDA’s agenda is intended to shed light on how generics makers can conduct comparative analyses for the device component of a combination product.

The agency’s announcement of the guidance follows increased concern over the FDA’s review of generics for Mylan’s EpiPen, which in less than a decade rose in price by about 400 percent. — José Vasquez