FDA BRIEF: Week of November 21, 2016FDA Voice


Opioid Question Collage (600x600)

PATIENT CONSIDERATIONS FOR OPIOID USE

Opioid use approved FDA to treat certain kinds of acute and chronic pain; also have very serious side effects.

Points to consider by patient:

  • Length of treatment
  • Reduction of potential side effects
  • History of addiction
  • Concomitant medications
  • Storage, Disposal, Sharing
  • Rx for Naloxone

READ


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CLINICAL TRIAL ENDPOINTS FOR CANNABIS USE DISORDER (CUD)

ISSUE:  4 M individuals in CUD; projected to increase

ENDPOINT CHOICES: What matters to people with CUD?  measurable/standarizable?changes linked to clinical benefits?

FDA TOOLS: Guidances on innovative approaches, Drug Development Tools,  Critical Path Innovation Meetings

READ


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TARGETED THERAPIES

FOR RARE DISEASES AND DISEASE SUBSETS : Natural History Data, Biomarker Use, Clinical Trial Design

CASE STUDIES: Lumizyme, Carbaglu, Cholbam,  Glucarpidase

  • Highly plausible mechanistic hypothesis
  • Natural history data on untreated patients
  • Highly plausible biomarkers
  • Serious unmet medical need
  • Relatively large treatment effect

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