A panel of regulators convened at the 2026 RAPS Convergence to discuss several initiatives underway in Europe to help ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
The US Food and Drug Administration (FDA) has published its proposed commitment letter for the Biosimilar User Fee Act (BsUFA IV) program, outlining several notable departures from the current ...
The Indian government has approved a program for monitoring adverse events associated with medicines and biological products used in organ and tissue transplantation. Hailed by the government as a ...
Michael Davis, the director of the FDA's Center for Drug Evaluation and Research (CDER), stated that increasing the availability of generic versions of glucagon-like peptide-1 (GLP-1) medications is a ...
Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, ...
Heidi Overton, President Donald Trump’s nominee to lead the US Food and Drug Administration (FDA), faced questions from both sides of the political aisle about her views on hot-button issues facing ...
Euro Roundup: EMA officials argue against making single pivotal trials the ‘rigid, default position’
Emer Cooke and other EMA leaders have weighed into the debate about whether sponsors should run one or two pivotal trials, arguing that the decision should be informed by the evidence needed to show a ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Foc ...
Audit-ready organizations don't wait for an audit to start checking whether their quality system works. They make sure their systems already control records as people access and update them, routinely ...
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