Grassley Mows Down FDA Handling Of ADHD Drug Safety
This article was originally published in The Pink Sheet Daily
Adverse events need a “comprehensive review,” Senate Finance Committee Chairman says, questioning FDA’s approach to advisory committees.
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The March 23 review of the new indication for modafinil, currently marketed as Provigil for narcolepsy, will likely focus on safety differences compared to other ADHD drugs.
Advisory alerts physicians to the risk of suicidal thinking in children and adolescents related to use of Eli Lilly's ADHD therapy atomoxetine.
Roche will consider requesting a re-examination of the negative decision by the Committee for Medicinal Products for Human Use.