In the ever-evolving landscape of biopharmaceuticals, companies face the immense challenge of managing regulated data and documents, which has become more complex due to the surge in global regulations. The increasing necessity for a unified Regulatory Information Management (RIM) solution that
The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is experiencing a transformative period marked by the recent appointment of Michelle Tarver as its new director. Tarver, a clinical ophthalmologist with extensive experience within the FDA, steps into her
Quantum BioPharma Ltd., a biotech firm specializing in neurodegenerative and metabolic disorders, has recently taken legal action against CIBC World Markets and RBC Dominion Securities. The lawsuit, filed in the United States District Court for the Southern District of New York, claims that these
Are Biopharma Companies Ready for Today's Regulatory Challenges? The biopharmaceutical sector is rapidly evolving, with companies constantly innovating to develop new treatments for a variety of diseases. However, navigating the regulatory landscape remains a significant challenge. Stricter
The U.S. Food and Drug Administration (FDA) recently paused clinical trials for Novavax's combination COVID-19 and influenza vaccine, as well as its standalone flu vaccine. This unexpected halt was prompted by a serious adverse event involving motor neuropathy in a participant from the Phase 2
The biopharmaceutical industry has been shaken by the European Union's recent ban on Triton X-100, a detergent essential for preventing viral contamination in biologics and plasma-derived products. Since its enactment in 2021, this regulatory change has catalyzed a worldwide search for
