Pharmacovigilance

The U.S. Food and Drug Administration has launched the REMS (Risk Evaluation and Mitigation Strategy) Public Dashboard to enhance access to data related to REMS programs using an interactive, secure, and web-based tool. Such a dashboard will help streamline user-friendly access for health care providers, research organizations, academia, industry professionals, and the general public to […]

Risk Evaluation and Mitigation Strategies (REMS) helps the FDA in ensuring that the benefits of a drug outweigh its risks. These strategies are particularly important for medications with significant safety concerns and require a well-structured approach to both design and assessment. The FDA’s guidance on the Risk Evaluation and Mitigation Strategy (REMS) logic model presents

Biological products are derived from living organisms or cells encompass a wide array of essential medical interventions, including vaccines, gene therapy products, and blood derivatives.  Thus, these products are relatively complex in nature which is why there is a need to maintain heightened vigilance and continuously monitor their safety and efficacy. It is crucial to

In the realm of healthcare, patients have a fundamental right to transparency and information regarding the procedures they undergo particularly with respect to medical devices used for surgical procedures. One often overlooks the aspect of this right which is the traceability labels for medical devices used in surgical procedures regardless of whether the device is