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A trade group has asked European authorities to give notified bodies access to the Eudamed database to empower them to deliver the risk-based ov…
Following months of negotiations with industry, the US Food and Drug Administration (FDA) has published its proposed commitment letter for the G…
Drug, regulatory, and laboratory animal testing groups want the US Food and Drug Administration (FDA) to ensure flexibility in choosing when to…
The US Food and Drug Administration recently issued warning letters to an over-the-counter (OTC) drugmaker in India for submitting falsified log…
The Indian government is preventing applicants who submit misleading, fake, or fabricated documents from filing further requests with regulatory…
The International Medical Device Regulators Forum (IMDRF) has finalized a technical document outlining how regulatory agencies may adopt predete…
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation…
Join expert speakers and seasoned professionals for an all-day, hands-on workshop where you’ll explore real-world applications of Artificial Int…