COFEPRIS, the Mexico regulatory authority, has mandated to transmit WHODrug Medicinal Product ID (MPID) and WHODrug Version in the E2B R3 report from 1 Jan 2024. This is to be used in pre-marketed and post-marketed cases – all drugs/vaccines (Suspect / Concomitant / Interacting / Historical Drugs). Click to access …
The US Food and Drug Administration (FDA) issued a much-awaited draft guidance on October 24, revising its approach to the dissemination of scientific informationon unapproved uses of approved/cleared medical devices and pharmaceuticals. The draft guidance replaces the 2014 document, “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices,” …
Medicines containing topiramate are registered for the treatment of epilepsy and for the prevention of migraine. Topiramate is known to cause birth defects in the baby if used during pregnancy. The European Medicines Agency’s (EMA) Risk Assessment Committee (PRAC) reviewed all available information, including the recently published results of three …