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Home » PhRMA Asks for Revisions to FDA’s 505(o)(4) Safety Labeling Guidance
PhRMA Asks for Revisions to FDA’s 505(o)(4) Safety Labeling Guidance
July 27, 2011
PhRMA says FDA’s guidance on drug safety labeling changes needs greater depth and detail to clarify just when the agency can require a drugmaker to change a drug’s label because of new safety data that has come to light.