The US Food and Drug Administration (FDA) last week finalized its guidance on postapproval manufacturing changes for biosimilars to better align with international guidelines and to better address ...
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) is planning to update a 2018 guideline on good pharmacogenomic practices. While the guideline is less than a ...
The US Food and Drug Administration (FDA) recently released a transparency roadmap outlining its achievements in FY 2026 and ...
Food & Nutrition FDA found Cyclospora during Taylor Farms inspection in Mexico (New York Times) (AP News) EU-funded project to develop novel technologies for continuous microbial monitoring in poultry ...
Australia’s Therapeutic Goods Administration (TGA) has adopted two new medicine labeling standards, starting a five-year countdown to mandatory compliance with the updated requirements. The old ...
Over the last 15 years, there has been an uptick in the number of patents associated with small-molecule drugs approved by the US Food and Drug Administration (FDA), with a majority of the increase ...
Learn how AI-enabled CER workflows can help regulatory teams improve efficiency, traceability, and MDR compliance while strengthening Notified Body readiness and preserving expert oversight. Most ...
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