fda

At a time when the world is transitioning from the mandatory HCP (healthcare professional) reporting, we have a fantastic pilot initiative from the FDA, for empowering consumer/patient reporting. Project Patient Voice is an online platform for patients and caregivers, along with their healthcare providers to look at patient-reported symptom data collected from cancer clinical trials. […]

“The best way to survive an FDA inspection is to be prepared for it!” An FDA Pharmacovigilance inspection is generally unannounced. However, if it pertains to a foreign/ Non-US site, it is likely to be a pre-announced one. What are the types of FDA Pharmacovigilance inspections? 1. Post Marketing Adverse Drug Experience (PADE) 2. Risk […]

The recent revocation of Ulipristal licence for the indication of uterine fibroids has once again reminded the Pharmacovigilance community about the importance of Drug-induced liver injury, or DILI. Incidentally, DILI is one of the commonest reasons for product withdrawals. Drug-induced liver injury (DILI) is uncommon, but a potentially fatal, cause of a liver disease that […]

The primary objective of Pharmacovigilance is to ensure that safe and effective medicines are available for Public Health. In August 2020, the FDA removed the Boxed Warning about amputation risk from the diabetes medicine canagliflozin, based on the review of new data from three clinical trials. This boxed warning was imposed in May 2017. Thanks […]