FDA “Xes” Letter Categories For Pregnancy Labels; Data Collection Drives Reg
FDA's proposed rule to update the format of the pregnancy and lactation sections of drug labeling does not require the firms collect new data about their products, but the agency is hoping to use various mechanisms to encourage them to do so
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FDA’s prescription drug regulations in the works include rules on generic drug labeling, compounding, bioequivalence reports and safety reporting for combination products.
Stakeholder meeting will address poor enrollment rates and other issues that undermine the utility of pregnancy registries, as well as the use of alternatives, such as case control studies and claims-based database studies.
HHS’s semi-annual inventory of rulemaking actions under development includes six prescription drug-related rules.