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
EU MDR Notified Body Designations Could Soar By A Third By End 2021
There could be 28 notified body designations in total under the Medical Device Regulation by the end of 2021. But there is cause for concern over designations under the IVD Regulation, which are lagging far behind.
Swiss Health Providers Turn Heat On Federal Council: 12% Loss Of Medtech Products Likely On EU MRA Failure
A consortium of Swiss providers, patient groups and health care trade bodies is imploring the federal council to avert a looming patient care crisis in Switzerland if the EU MRA cannot be agreed.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: