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To help relieve uncertainty among sponsors about its role in regulatory decisions, the FDA will publish guidance on its application of real-world evidence to drug approvals and post-market evaluations, FDA Commissioner Scott Gottlieb told the National Academy of Sciences. Read More
To curb abuse of the Hatch-Waxman system, the FDA should consider allowing generic drug manufacturers to create their own REMS, according to CVS Health. Read More
Drug sponsors should ask themselves three data integrity questions before the FDA can, according to John Avellanet, managing director and principal consultant at Cerulean Associates, during an expert panel at the RAPS’ 2017 Regulatory Convergence meeting. Read More