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Agency’s ongoing work to forcefully address the opioid crisis

FDA addressing opioid crisis forcefully

  • Cut the rate of new addiction
  • Stepped up enforcement of marketing and sale of illicit opioids
  • Novel product innovation for opioid addiction treatment, non-addictive pain treatments
  • New Opioid Policy Steering Committee

Progress

  • Extension of risk evaluation and mitigation strategy program for immediate release formulations of opioid drugs
  • Broad effort to develop evidence-based guidelines for opioid prescribing
  • Protect children from unnecessary exposure to certain opioids in prescription cough and cold medicines
  • Requested market withdrawal of Opana ER based on risks that manifest only when  misused and abused
  • Enforcement actions collaboration with the Federal Trade Commission on unapproved product websites
  • Sharply expanded oversight of drugs being shipped illegally through international mail facilities
  • Expanded new pathways for the development of safe and effective treatments for addiction
  • New regulatory guidance to promote abuse-deterrent formulations of opioid drugs
  • Innovation challenge for medical devices and mobile applications as alternatives to oral opioids
  • Public meetings on Opioid Use Disorder and on Chronic Pain

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Complex Innovative Trial Designs Pilot Program

Goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs

  • Pilot program offers sponsors increased FDA interaction to discuss proposed  CID approach

Goals

  • Use of CID approaches in late-stage drug development
  • Publicly discuss trial designs to promote innovation

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Capture.JPGFDA’s Comprehensive Effort to Advance New Innovations: Initiatives to Modernize for Innovation

Innovating new operating system to meet FDA goal for medical care – right drug or device delivered to right patient at right time

  1. Modernizing Clinical Trials for Drugs and Devices
  2. Modernizing FDA’s Organization and Breaking Down Outdated Silos
  3. Harnessing Real World Evidence
  4. FDA’s Role in Curating Standards for Novel Technologies

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Image credit: FDA

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