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The FDA is accusing two Chinese API manufacturers of doctoring laboratory results, with one cited for falsifying lab reports and the other for running both official and unofficial tests. Read More
The FDA handed a 10-observation Form 483 to a Texas manufacturer for sterility shortcomings, inadequate testing of products and deficient recordkeeping. Read More
GW Pharmaceuticals’ cannabis-based Lennox-Gastaut syndrome treatment Epidiolex shined in a Phase 3 trial, reaching its primary endpoint of a significant reduction in the monthly frequency of atonic seizures compared to a placebo over a 14-week treatment period. Read More