As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Source: Drug Industry Daily

Withings’ Body Scan health station received FDA clearance for its weight-scale style device that provides users a home electrocardiogram (ECG). Source: Drug Industry Daily

As word comes out that the Biden Administration may do a two-days-early reveal on the 10 drugs to be discounted through the Inflation Reduction Act (IRA), another pharma company —…

CVS Health has launched a subsidiary, Cordavis, to work directly with manufacturers to commercialize and/or co-produce FDA-approved biosimilar products at more affordable prices. Source: Drug Industry Daily

The FDA “does not intend” to enforce the Drug Supply Chain Security Act (DSCSA) requirement that manufacturers electronically capture and share data that will track a drug at the individual…

Over the past week, the FDA issued a draft guidance on product-specific guidances, extended the comment period on a draft guidance for human cellular and gene therapy products, published a…

The FDA has announced a new testing tool, and approved several systems for cryoablation, donor lung preservation and cervical disc replacement. Source: Drug Industry Daily

HHS announced a slate of new funding initiatives this week, including $1.4 billion for Project NextGen to support development of novel COVID-19 technologies and $24 million for Curing the Uncurable…

Draeger Medical has voluntarily recalled its Carina Sub-Acute Care ventilators — which the FDA has deemed a class I recall — to address the potential presence of contaminants in the…

This month, FDAnews tackles studies for two promising obesity drugs, a first-of-its-kind pneumococcal vaccine for adults and a partial clinical hold for a blood cancer drug. Source: Drug Industry Daily