The FDA has issued a new final guidance on assessing COVID-19-related symptoms in drug and biologics trials for outpatient prevention/treatment of the infectious disease, overriding its prior recommendations from September…

Over the past week, the FDA issued a final rule adding the Digital Health Advisory Committee to the list of standing committees, final guidance on COVID-19 symptoms in clinical trial…

While three of the companies warned of inappropriate Orange Book patent listings by the FTC are delisting all the challenged patents, according to the U.S. legislators who led the action,…

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device manufacturers who are experiencing financial hardship — and are in an active bankruptcy — can look to a new FDA draft guidance for information on how to…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