• 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 ...
  • Regulatory NewsRegulatory News

    FDA Revises Labeling Guidance to Clarify Clinical Pharmacology Recommendations

    A new draft guidance document published by the US Food and Drug Administration (FDA) seeks to help sponsors with the "clinical pharmacology" sections that accompany an approved drug's labeling. Background Clinical pharmacology refers to how a drug is expected to affect a patient using the drug, and includes information obtained from pharmacodynamic and pharmacokinetic research (i.e. how a drug interacts with the body, and to what extent), as well as from adverse event a...
  • FDA Moves Forward With Drug Labeling Revision Project

    The US Food and Drug Administration (FDA) is out with new information about an initiative first announced in 2013 that is meant to convert the labeling of hundreds of older drugs into a newer and consumer-friendly format. Background In 2006, FDA passed the Physician Labeling Rule (PLR), a labeling format intended to make it easier for physicians and patients to understand some of the most important benefits and risks of a drug. For example, labeling highlights under...