Manufacturers of certain critical medical devices will soon be required to flag potential shortages as part of the EU’s updated regulations. Source: Drug Industry Daily

AdvaMed has published seven “foundational” principles to guide innovations, policymaking and regulation in AI and machine learning (ML) for medtech as part of an information blitz that includes an overview…

Smartwatches and smart rings that claim to measure blood glucose levels without piercing the skin have not been authorized, cleared or approved by the FDA, the agency has warned in…

Small medical device manufacturers who are experiencing financial hardship — and are in an active bankruptcy — can look to a new FDA draft guidance for information on how to…

Chinese pharmaceutical company Sichuan Deebio Pharmaceutical has suspended manufacture of at least one active pharmaceutical ingredient bound for the U.S. marketplace and may be banned from importation altogether if it…

This edition of Quick Notes looks at significant drug approvals, including the first cellular therapy for patients with unresectable or metastatic melanoma, a drug to reduce accidental food allergy reactions,…

The General Accountability Office (GAO) should press the FDA to stop being passive in its oversight of device safety and instead take a more bold and active role, according to…

Enhanced access to real world data (RWD) sources critical to regulators, pharma companies and researchers is the objective for the two electronic catalogues launched last week by the European Medicines…

This edition of Quick Notes looks at consequential new drug approvals, including a first drug for frostbite, a first of its kind gene therapy authorization for sickle cell disease and…

Judges from the U.S. District Court of Massachusetts have revived a nearly 12-year-old lawsuit that charged Sanofi with damaging the health of patients with a rare liver disease by selling…