FDA: New Generic Labeling Guide Doesn't Signal Policy For Broader Rule

FDA says newly issued guidance requiring producers of generic drugs that lack a marketed reference product to propose labeling updates when new safety or efficacy data emerge has no bearing on what direction the agency will take in a broader, contentious generic drug labeling rulemaking. Stakeholders are split regarding the relevance of the new guidance. A key public advocacy group is calling the guidance a small step forward in requiring generics to update their labeling. However, an industry insider sees...