FDA “Flexibility” Presages Good Climate in 2012 for Approval Decisions, Shortage Situations

By Cole Werble / Email the Author / The RPM Report January 2012, Vol. 8, No. 2
Feature Articles / Word Count: 3502 / Article # 2012500018

Executive Summary

As FDA girds for the Capitol Hill phase of the user fee reauthorization push in 2012, the agency is projecting an image as a flexible problem-solver. FDA’s underlying message: the agency has sufficient authority and does not need tinkering with the legislative mandate. From the drug industry’s perspective, a continued stress on flexibility through the first nine months of the year could create a favorable climate for application reviews and for resolving lingering manufacturing issues.