Clinical research has long been a cornerstone of advancing medical science, characterized by a significant historical trajectory. Over decades, its momentum has increased with the advent of new knowledge and technologies, enabling the development of improved therapeutics. From the discoveries in
In light of potential regulatory relaxations under the Trump administration, South Korean pharmaceutical and biotech companies are eagerly eyeing the opportunities to secure FDA approvals for their innovative drugs. This ambitious pursuit has been catalyzed by the prospect of a more lenient
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 l
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
