FDA BRIEF: Week of August 8, 2016

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DENIAL : Petitions to Reschedule Marijuana

  • 2 petitions to reschedcule marijuana from Schedule I (high abuse risk, no therapeutic value) to Schedule II (high abuse risk, with therapeutic value) based on:
    • Accepted medical use in US
    • Safe for use under medical supervision

    • Low abuse potential for medical use

  • DEA consulted with FDA and NIDA on scientific evaluation of efficacy/safety and scheduling recommendation
  • DENIED rescheduling requests:
    • Marijuana has a high potential for abuse. Based on additional data gathered by DEA

    • Marijuana has no currently accepted medical use in treatment in US. Chemistry is not known and reproducible; no adequate studies on safety and efficacy; not accepted by qualified experts, scientific evidence is not widely available

    • Marijuana lacks accepted safety for use under medical supervision. No FDA-approved marijuana product, no NDA under FDA review. Known risks outweighed by specific benefits in well-controlled clinical trials that scientifically evaluate safety and efficacy

  • Product needs to be approved by FDA prior to rescheduling

Federal Register responses  READ  AND READ

INCREASE: Number of Authorized Marijuana Manufacturers Supplying Researchers

  • Policy change to expand DEA- registered marijuana manufacturers
  • Consistent with the CSA and U.S. treaty obligations
  • Allow additional entities for DEA registration to grow and distribute marijuana
  • Facilitate research and development of products

READ

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