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Home » House Draft’s GMP Fix Redundant, Would Bog Down Reviews: Woodcock
House Draft’s GMP Fix Redundant, Would Bog Down Reviews: Woodcock
May 7, 2012
CDER Director Janet Woodcock is urging House lawmakers to excise from their omnibus user fee draft a provision that would expedite manufacturing changes to speed shortage drugs to market, saying it’s not needed because the FDA already has the tools to make such fixes.