FDA recently launched a public dashboard within the FDA’s Adverse Event Reporting System (FAERS) to improve access to data on adverse events related to drug and biological products. FDA Commissioner Scott Gottlieb, M.D. stated, “Tools like [FAERS] are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and
The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current confidentiality arrangements that apply to the cooperative law enforcement activities conducted by the regulators. The new confidentiality commitment allows the regulators to share
The European Medicines Agency (EMA) has begun running a series of modular training courses to support stakeholders in using EudraVigilance, the centralized database for managing information on suspected adverse reactions reported with medicines authorised in the European Economic Area (EEA).
On 27 April 2015, the European Medicines Agency (“EMA”) launched a public consultation on its Good Pharmocoviligance Practices (“GVP”) concerning educational materials. The draft guidelines are contained in GVP Module XVI Addendum 1.
On 14 April 2015, the European Medicines Agency (“EMA”) published three draft guidance documents concerning medication errors for consultation. The new European Union (“EU”) laws and regulations governing pharmacovigilance activities require reports of suspected adverse reactions arising from an error associated with the use of a medicinal product to be reported to EudraVigilance. To support