FDA Brief: Week of Feb 1, 2016


FDA Voice


Sweeping Review of Agency Opioids Policies

 Dr. Robert Califf, Deputy Commissioner for Medical Products and Tobacco

To addres opioid abuse epidemic:

  • Develop policies to reverse epidemic while providing access to effective relief
  • Re-examine the risk-benefit paradigm to consider wider public health effects
  • Convene Advisory Committee prior to non abuse-deterrent opioid approval
  • Consult with Pediatric Advisory Committee on labeling
  • Include additional warnings and safety information to existing labeling
  • Update REMS requirements
  • Expand access to abuse-deterrent products
  • Improve access to naloxone for use disorders
  • Support alternative pain management options

Complements U.S. Health and Human Services initiative focusing on 3 priority areas:

  1. Providing training and educational resources,updated prescriber guidelines
  2. Increasing use of naloxone to reduce overdose deaths
  3. Expanding use of Medication-Assisted Treatment for substance use disorders




Modernizing Pharmaceutical Manufacturing to Improve Drug Quality: Ensuring a Safe and Adequate Supply of Drugs

Michael Kopcha, Ph.D., R.Ph. Director, Office of Pharmaceutical Quality, CDER

To avoid drug shortages, FDA proposing and adopting  novel technologies to produce quality medicines that are safe and effective

  • Expedite review of ANDAs when potential shortage issues arise with approved drugs
  • Embrace advanced manufacturing technologies that improve quality, increase efficiency, reduce product failures
  • Modernize pharmaceutical manufacturing by encouraging new technologies
  • Guide and Approve emerging technology

Accomplishments thus far:

  1.  First 3D printed pill Spritam (levetiracetam) approved
  2. Emerging Technology Team to assist industry identify and resolve technology issues
  3. Draft Guidance Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base.




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