FDA To Sponsors: Say Goodbye To MedGuide-Only REMS
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Lamictal XR's Monotherapy Claim May Spur More Historical Control Trials
GlaxoSmithKline’s anti-epileptic drug Lamictal XR gained approval for conversion to monotherapy without any post-marketing commitments despite concerns about the novel trial design employed for the application.
Lamictal XR's Monotherapy Claim May Spur More Historical Control Trials
GlaxoSmithKline’s anti-epileptic drug Lamictal XR gained approval for conversion to monotherapy without any post-marketing commitments despite concerns about the novel trial design employed for the application.