Recon: FDA says Replimune's pivotal melanoma study failed to show benefit; FDA guidance on peptides could affect development ...

The World Health Organization (WHO) has published its first interim list of 12 global medical device regulators eligible for ...

The European Medicines Agency (EMA) has issued notices stating how it will comply with certain stakeholder information protection under the Data Protection Regulation for EU institutions, bodies, ...

By the end of a two-day meeting that concluded Friday afternoon, an advisory committee to the US Food and Drug Administration ...

The European Commission on Monday published new guidelines to assist providers and deployers of artificial intelligence (AI) ...

Time between a drug’s entry into clinical trials and its approval for reimbursement was similar in four major markets, according to a cross-sectional analysis published in JAMA Health Forum.

Australia’s Therapeutic Goods Administration (TGA) recently announced that it has adopted 23 international scientific guidelines from European Medicines Agency (EMA), the International Council for ...

RAQA Leadership Retreat 2026 Join the RAPS Switzerland Chapter RAQA Leadership Retreat 2026 in the Swiss Alps for two days of expert-led discussions, peer exchange, and practical insights designed for ...

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, ...

Industry stakeholders have asked the US Food and Drug Administration (FDA) to provide more clarity in a recent draft guidance aimed at helping sponsors determine dose selections using a quantitative ...

The US Food and Drug Administration (FDA) has finalized guidance detailing the information that sponsors must submit in a pre-submission facility correspondence (PFC) for priority review of ...