Epidiolex Advisory Committee Appears To Be Covering US FDA's Bases, But Liver Injury Concerns Persist
Panel for first-ever marijuana derivative will discuss safety issues, including link to transaminase elevations, but low potential for abuse and strong efficacy suggest a smooth route to approval.
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Epidiolex May Have Avoided CRL Over Metabolite Assessment Due To Unmet Need
Lead pharmacology/toxicology reviewer said Epdiolex was not approvable because of inadequate assessment of 7-COOH-CBD human metabolite, but supervisor said it could be conducted in postmarketing phase because of the unmet need the drug fills.
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.
Keeping Track: Pre-Independence Day Fireworks Crackle At US FDA With Burst Of Approvals And Filings
The latest drug development news and highlights from our US FDA Performance Tracker.