ODE-1 Director Unger, Not Medical Officer, Conducted Epidiolex Safety Review

Highly unusual move of an ODE director leading clinical review of a drug had nothing to do with public sentiment regarding Epidiolex's derivation from marijuana, US FDA says; Unger instead wanted to use the review as an example for future reviews to rely more on the agency's analyses rather than those of applicants.

Drug Review Profile regular column

GW Pharmaceuticals PLC's epilepsy treatment Epidiolex (cannabidiol) has been regarded as highly unusual in that it is now a US FDA-approved drug that is derived from marijuana. Just as unusual, however, is a factor that helped it clear the agency approval hurdle: a review of the safety data led by Office of Drug Evaluation I (ODE-1) Director Ellis Unger.

Reviews of clinical data are almost always conducted by medical officers. The review of the Epidiolex safety data, however, was...

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