FDA Brief: Week of Mar 21, 2016

 

biotrial

 

Enhanced warnings for immediate-release (IR) opioid pain medications related to risks of misuse, abuse, addiction, overdose and death

 

  • Continuing effort to educate prescribers and patients about the potential risks related to opioid use
  • Class-wide safety labeling changes for IR opioid pain medication
    • New boxed warning : serious risks of misuse, abuse, addiction, overdose, death
    • Safety risk additional information

READ

Draft Guidance on Abuse Deterrence Evaluation of Generic Oral Opioids

abuse

  • For approval with ‘abuse deterrence’ in labeling
  • Assessment of
    • Routes of abuse
    • Comparative in vitro studies and others(multiple strengths, PK)
    • Data analysis
    • Additional studies – Mechanical manipulation, Abuse by injection, ingestion, insufflation, smoking

READ


 

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