FDA/EMA/Industry Action On PML Heralds New Foray Into Collaboration
FDA, the European Medicines Agency and the pharmaceutical industry have embarked on a new cooperative effort to develop solutions to drug-related progressive multifocal leukoencephalopathy – a collaboration that could be a springboard for better disease/drug-specific cooperation.
You may also be interested in...
Partners Biogen Idec and Elan had asked both European and U.S. regulators to update the label to include the addition of anti-JC virus antibody status as a risk factor, but so far only the EU has moved toward JCV testing.
The "chatter" between reviewers and scientists at FDA and the European Medicines Agency appears to be increasing as the two bodies move toward renewing their confidential information sharing agreement
Market withdrawal of Genentech's psoriasis drug Raptiva (efalizumab) shows FDA under new leadership acting decisively on drug safety - especially in cases where comparable treatment alternatives exist