FDA's Drug Review Process: Continued the FDA rely on data submitted by sponsors abbreviated version of the approval process for new drugs complete response letters two pathways for a drug to obtain approval The Role of User Fees complete response letter complete response letters The Role of User Fees According to the FDA FDA's Drug Review Process: Continued The Role of User Fees FDA Approval complete response letter complete response letters outweigh the risks Drug Review Steps Simplified FDA's Drug Review Process: Continued complete response letter Occasionally the FDA requests additional data