FDA updates on multifaceted plan to combat opioid crisis [Seeking Alpha]
Endo International plc - Ordinary Shares (ENDP)
Last endo international plc - ordinary shares earnings: 2/26 06:00 am
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Source: Seeking Alpha
FDA updates on multifaceted plan to combat opioid crisisIn astatement, FDA Commissioner Scott Gottlieb, M.D. outlines the FDA's many initiatives aimed at addressing the U.S. opioid crisis. Key points:Risk evaluation and mitigation strategy (REMS) guidance updated to cover immediate-release formulations of opioids. Educational content added on non-opioid alternatives. Training extended to non-physician prescribers.Evidence-based guidelines in development for opioid prescribing, aimed principally at reducing the number of pills prescribed to better match the medical need (eliminate over-prescribing).New safety labeling changes implemented for prescription opioid cough and cold medicines that may be used by children younger than 18 years old.Requested the market withdrawal of Endo International's OPANA ER (oxymorphone HCl) due to the risks when abused and misused. New guidance being developed to explain how the agency considers these risks in its regulatory decisions.Warning Letters sent
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