Business · 10/07/2008

FDA Amends Regulations for New Drug Applications and Abbreviated New Drug Applications

The US Food and Drug Administration (FDA) has updated its rules for reviewing new drug applications and generic drug applications, aiming to streamline the approval process and meet user fee performance goals set by the Prescription Drug User Fee Amendments of 2002 (PDUFA III). The changes include the use of complete response letters to indicate the outcome of application reviews, replacing approvable and not approvable letters.