A new draft guidance from the US Food and Drug Administration (FDA) gives industry direction in how to assess drug-drug interactions for therapeutic proteins.
Posted: August 10, 2020, 9:06 pm
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 Devices Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR).
Posted: August 10, 2020, 8:41 pm
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its expectations for application holders required to submit marketing status notifications when their products are withdrawn from sale or are not available for sale.
Posted: August 10, 2020, 8:25 pm
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Posted: August 10, 2020, 5:14 pm
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 procurement of domestic goods.
Posted: August 7, 2020, 9:02 pm