The FDA Process for Approving Generic Drugs.pptVIP

The FDA Process for Approving Generic Drugs Gary J. Buehler, R.Ph. Dale Conner, Pharm. D. Director Director, Division of Bioequivalence Office of Generic Drugs Did you know that generic drugs... Are safe and effective alternatives to brand name prescriptions Can help both consumers and the government reduce the cost of prescription drugs Are currently used in 50% of all prescriptions dispensed Save an average of $50 for every prescription sold Hatch-Waxman Amendments to FFDC Act - 1984 Considered one of the most successful pieces of legislation ever passed Created the generic drug industr