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    EMA Consults on Regulatory Requirements for Chronic Liver Disease Drugs

    The European Medicines Agency (EMA) on Thursday launched a public consultation to gather input on a future reflection paper discussing the regulatory requirements for developing drugs to treat chronic non-infectious liver diseases. According to the agency, there is an unmet medical need for drugs to treat chronic non-infectious liver diseases such as non-alcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). And wh...
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    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...
  • Dosing Recommendations in Patients with Kidney Damage Focus of Revised EMA Guideline

    The European Medicines Agency (EMA) has released for consultation a new guideline on assessing the preclinical safety of products intended to be used by patients with decreased renal function. The kidney is responsible for filtering waste products from the body, among other essential functions. In patients with decreased renal function, the kidney is sometimes unable to process all metabolized chemicals (such as those from pharmaceutical products) out of the body, leadin...