Tysabri Risk Management Plan Needs Strengthening, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency calls for additional restrictions in prescribing, dispensing and use.
You may also be interested in...
Tysabri Marketing Unaffected By Proposed Risk Management Plan
Marketing of Biogen Idec/Elan's Tysabri would not be restricted by the companies' proposed risk management plan, CDER Office of Medical Policy Director Robert Temple said during a press briefing following an advisory committee meeting on the product's reintroduction
Tysabri Marketing Unaffected By Proposed Risk Management Plan
Marketing of Biogen Idec/Elan's Tysabri would not be restricted by the companies' proposed risk management plan, CDER Office of Medical Policy Director Robert Temple said during a press briefing following an advisory committee meeting on the product's reintroduction
Tysabri Revised RiskMAP Would Have Mandatory Patient/Physician Registry Enrollment
Biogen Idec’s revised risk management plan for its multiple sclerosis therapy Tysabri adopts most changes sought by FDA in a critique of the company’s original risk plan.