The European Commission on Tuesday published the results of a yearslong evaluation of the EU’s orphan and pediatric medicines regulations it says will be used to guide future legislative changes and shape the EU pharmaceutical strategy.

Welcome to Asia-Pacific Regulatory Roundup, our weekly overview of the top regulatory news from the Asia-Pacific region.

A new draft guidance from the US Food and Drug Administration (FDA) gives industry direction in how to assess drug-drug interactions for therapeutic proteins.  

In a new guidance document, the European Commission’s Medical Device Coordination Group (MDCG) details how notified bodies can reference Medical Device Single Audit Program (MDSAP) audit reports when planning surveillance audits under the Medical ...

The US Food and Drug Administration (FDA) on Monday finalized its guidance on marketing status notifications for new and generic drugs, clarifying its expectations for application holders required to submit marketing status notifications when thei...

President Donald Trump on Thursday signed an executive order aimed at onshoring the production of essential drugs, medical devices and critical inputs for those products to reduce US reliance on foreign manufacturing and promoting federal procurem...