The U.S. Food and Drug Administration Archives - CDR

Research says over one-third of pre-approved Rx drugs have not completed the FDA approval process

August 26, 2019 by Chain Drug Review drug manufacturers are failing to complete the approval process, Liang (Leon) Xu, NFORMS journal Manufacturing & Service Operations Management, The Food and Drug Administration’s (FDA) Accelerated Approval Program, The U.S. Food and Drug Administration Leading Headlines, Pharmacy

CATONSVILLE, Md. – The Food and Drug Administration’s (FDA) Accelerated Approval Program was created in 1992 to significantly accelerate the ability to bring certain new drugs to market. New research published in the INFORMS journal Manufacturing & Service Operations Management reveals a large number of drug manufacturers are failing to complete the approval process, meaning a

Government shutdown having major effect on FDA

January 19, 2019 by Chain Drug Review Dr. Scott Gottlieb, Government shutdown, The U.S. Food and Drug Administration Leading Headlines, Pharmacy

WASHINGTON — The U.S. Food and Drug Administration has roughly five weeks of funding left to review new drug applications during the shutdown, commissioner Dr. Scott Gottlieb reported this past week on Twitter. Many experts predict this could have a ripple effect, bogging down the approval and manufacture of new drugs, delaying patients from getting these treatments and