FDA DEFICIENCY LETTERS ARE A "GREEN LIGHT" IN THE APPROVAL PROCESS

Executive Summary

FDA DEFICIENCY LETTERS ARE A "GREEN LIGHT" IN THE APPROVAL PROCESS, FDA Investigations & Compliance Branch Chief Mark Lynch asserted at the Sixth International Congress of the International Society for Pharmaceutical Engineering. Lynch, addressing the organization in Philadelphia May 11 on "Pre- and Post-Approval Inspections," said many companies and FDA investigators incorrectly construe the letters to mean that an application has a "fatal flaw," when "in fact it is also an indication that the application is approvable."