The United States Food and Drug Administration (“FDA”) released four new draft guidances on October 2, 2017 that aim to reduce the barriers for certain generic drugs to enter the market and ultimately, reduce drug prices. Reducing drug prices was
FDA issues 48 product-specific bioequivalence recommendations for generic drugs
On June 29, 2015, FDA released 44 new and 4 revised product-specific bioequivalence recommendations for the development of generic drugs. FDA has now published a total of 1321 bioequivalence recommendations, listed by the active ingredient, on its website.
Under