
FDA Looks to Modernize Generic Drug Labels
FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.
On Dec. 13, 2018, FDA Commissioner Scott Gottlieb, MD,
“These actions are part of our ongoing commitment to promote a framework that ensures that generic drug labels reflect up-to-date, science-based information to inform patients and providers, while also balancing the need to maintain a pathway for the development of generic drugs that is modern, efficient and low cost.
“As with all decisions we make, we carefully weighed the potential benefits of this proposed rule against the challenges it could impose. We want to provide background on this process, the FDA’s decision and the overarching public health considerations that were weighed. And, more broadly, we want to outline some of the current efforts the FDA is undertaking to help modernize generic labels,” Gottlieb said in a
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