Pediatric ADHD drug safety
Executive Summary
FDA's Pediatric Advisory Committee will address neuropsychiatric and cardiovascular events possibly related to attention deficit/hyperactivity disorder drugs at a March 22 meeting. The meeting is a continuation of the discussion begun at a June 2005 meeting. At that time, the committee discouraged labeling changes to Johnson & Johnson's Concerta and other methylphenidate products to address psychiatric and cardiovascular events (1"The Pink Sheet" July 4, 2005, p. 3). The pediatric meeting will follow a Feb. 9 meeting of FDA's Drug Safety & Risk Management Advisory Committee on ADHD drug cardiovascular safety (2"The Pink Sheet" Jan. 9, 2006, In Brief). The meeting will be held at the Hilton in Gaithersburg, Md. beginning at 8 a.m...
You may also be interested in...
Concerta Adverse Events Update On “Drug Watch” Web Site Advised By Cmte.
FDA should consider posting concerns about psychiatric and cardiovascular adverse events with Johnson & Johnson's Concerta and other methylphenidate products on the agency's upcoming "Drug Watch" website, members of FDA's Pediatric Advisory Committee said
Israel's Gamida Cell Survives By Selling To Lender
Having finally secured US approval for Omisirge, Gamida was hoping to bag a strategic partner for the cell therapy. A year on, no suitable partner has been identified and the firm is delisting from the NASDAQ and going private.
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.