- EMA Seeks Experts on Clinical Data Anonymization
The European Medicines Agency (EMA) on Wednesday issued a call for experts to join a new technical advisory group for anonymizing clinical data.
- Woodcock, Industry Groups Tell House E&C Committee PDUFA Reauthorization Delays Could be Dire
Leaders from the biopharmaceutical industry lobby and a patient advocacy group on Wednesday urged members of the House Energy and Commerce Committee to reauthorize the sixth iteration of the Prescription Drug User Fee Act (PDUFA VI).
- Regulatory Recon: FDA Approves Newron’s Xadago as Add-On for Parkinson’s Disease; Novartis Heart Drug Serelaxin Fails in Phase III Trial (22 March 2017)