Zebra coalition petitions FDA
February 4, 2014
A petition spearheaded by the Zebra Coalition, brought together by MPNforum, asks that the FDA require a Patient Advocate be available at every Investigative New Drug clinical trial site to provide a needed level of Patient safety. The Patient Advocate would be empowered to communicate directly with Patients and with Investigators on behalf of Patients.
This initiative comes in the wake of the November 2013 announcement by Sanofi that they are discontinuing drug trials for their compound SAR302503 (Fedratinib) which was found to have neuro-toxicity for patients on the trial.