Tag archives: generic drugs

FDA releases new guidances on increasing generic drug competition

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 a stated objective of President Trump during his campaign and has also been a topic … Continue reading

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 21 CFR 320.24, applicants must conduct bioequivalence testing using the most accurate, sensitive, and reproducible approach … Continue reading