Rare diseases (also referred to as orphan diseases) are diseases that affect less than 5 in 10,000 people in Europe or fewer than 200,000 people in the United States. Although each rare condition affects only a small population, it collectively affects more than 350 million people worldwide and can severely affect a patient’s quality of […]
Advanced Pharmacovigilance Strategies for Rare Disease Drugs Read More »
Risk Evaluation and Mitigation Strategies (REMS) is a drug safety program required by the US FDA for certain medicines that are associated with safety concerns. They typically accompany applications to the US FDA, like New Drug Applications, Biologics License Applications, or Abbreviated New Drug Applications (ANDA), that describe drug safety and ensure that the drug’s
Risk Evaluation and Mitigation Strategies (REMS) for US Drug Development Read More »
The healthcare landscape of Latin America is evolving with pharmacovigilance taking the spotlight to ensure patient safety and regulatory compliance. While there are many contenders of this region, Mexico standards out as a key player with its proactive approach to adverse event monitoring and international alignment that is shaping the future of drug safety in
Exploring Pharmacovigilance Processes in Mexico Read More »
In the rapidly evolving landscape of pharmaceutical safety, integrating Artificial Intelligence (AI) into literature monitoring in pharmacovigilance processes has become necessary. It involves ongoing monitoring and assessment of adverse drug reactions (ADRs), and other potential risks associated with medicinal products. A critical aspect of PV is literature monitoring, which entails reviewing scientific literature, case reports, and
Harnessing AI for Enhanced Literature Monitoring in Pharmacovigilance Read More »
Medical Devices are an important part of the healthcare delivery system used in the diagnosis, monitoring, and management of diseases. Recent scientific innovations and technological solutions have expanded the use of medical devices globally. Medical devices can include items such as apparatus, instruments, appliances, substances, in-vitro reagents, software, etc. and other related objects used for
Identifying Barriers in Reporting Medical Device Adverse Effects Read More »
As the healthcare and pharmaceutical industries increasingly turn to data-driven solutions, the integration of real-world data (RWD) into regulatory decision-making has emerged as a key focus for enhancing pharmaceutical practices. Utilizing data from Electronic Health Records (EHRs) and medical claims can provide valuable insights into patient care and treatment outcomes. This strategy has the potential
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
FDA Launches REMS Public Dashboard to Enhance Transparency and Data Access Read More »
The Declaration of Helsinki (DoH), the first international set of ethical guidelines for medical research involving human participants, marked its 60th anniversary this year. The members of the World Medical Association (WMA) General Assembly gathered to and unanimously approved significant revisions to the DoH. The DoH has always established that medical research involving human participants
Updates to the Declaration of Helsinki Read More »
Pharmacovigilance practices are associated with several challenges related to collection of safety data, processing, assessment, and volume of patient safety data. As technological disruptors- like artificial intelligence (AI)- develop, so do the solutions to tackle such challenges. This leads to more efficient pharmacovigilance (PV) systems and processes that ultimately enhance drug safety monitoring. Whether it
Emerging Drug Safety Technology Program Read More »
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
REMS Logic Model: Framework to link program design with assessment Read More »
