• Regulatory NewsRegulatory News

    FDA Amends Liver Warning Labeling Guidance for Some OTC Drugs Containing Acetaminophen

    The US Food and Drug Administration (FDA) on Monday unveiled amended guidance on the liver warnings that must be contained in labels of some over-the-counter (OTC) drugs containing acetaminophen, saying it will allow manufacturers in some cases to warn patients against taking more than 4,000 mg of acetaminophen in 24 hours. The guidance, which was initially issued in 2012 , helps to clarify certain cases where manufacturers of internal analgesic, antipyretic and antirh...
  • Regulatory NewsRegulatory News

    FDA Recommendations Aim to Make Liquid Acetaminophen Safer for Children

    US regulators are out with new advice for companies developing acetaminophen-based products, saying they need to be labeled with specific statements so as to prevent children from coming to harm. Background Acetaminophen is commonly used in internal analgesic, antipyretic and antirheumatic (IAAA) drugs to relieve pain, but has also been associated with liver injury and stomach bleeding if used at high dosages. Over the years, FDA has taken several actions meant to lim...
  • As Oceanic Regulator ANZTPA Comes Online, Harmonization Efforts Yield Results

    The regulatory systems of Australia and New Zealand have been slowly merging over the last few years, with the stated end goal of being able to provide better regulatory services at a lower cost to the taxpayers of each respective country. The Australia New Zealand Therapeutic Products Agency (ANZTPA), as the merged agencies will be called, has slowly been making note of its milestones over the last few years as it builds its regulatory capacities up and out. In Septe...