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CDER lacks the resources to review clinical trial monitoring plans voluntarily submitted for FDA feedback as suggested in a 2011 guidance, the center says.
The FDA is warning a pharmacy in Vancouver for continuing to sell its unapproved clobazam to U.S. patients despite the agency’s approval of Lundbeck’s Onfi in 2011.
An investigational oral testosterone replacement from Clarus Therapeutics has had promising results in Phase III and could be an alternative for men taking transdermal or injectable products.
The FDA has been handed additional authority to vet the clinical trial information submitted to ClinicalTrials.gov.
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