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  • Regulatory NewsRegulatory News

    FDA revises draft PLLR guidance

    The US Food and Drug Administration (FDA) on Wednesday revised its draft guidance providing recommendations on the content and format of labeling required under the pregnancy and lactation labeling rule (PLLR).   The draft guidance was first issued alongside the final PLLR in 2014, with the rule itself taking effect in June 2015. The PLLR revised labeling requirements under the 2006 physician labeling rule, to “provide a framework for clearly communicating information ...
  • Regulatory NewsRegulatory News

    FDA Scraps Pregnancy Labeling Classification System in Favor of New Standard

    The labeling on many prescription drug products approved after 2001 will need to be reconfigured to include clearer information about whether a drug is safe to use during pregnancy, the US Food and Drug Administration (FDA) announced today. Background Prescription drug labeling has been subject to standardization measures in the US since 1979, when measures to introduce labeling uniformity were first passed. Those measures were substantially updated in 2006 under FDA's ...