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Over the past week, the FDA issued a draft guidance on product-specific guidances, extended the comment period on a draft guidance for human cellular and gene therapy products, published a…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

Although unanimously endorsing the safety of Medtronic’s Symplicity Spyral Multi-electrode Renal Denervation system, members of the FDA’s Circulatory System Devices Panel were split on both the efficacy and risk/benefit balance…

Apellis Pharmaceuticals’ safety probe into reports of retinal vasculitis linked to its eye drug-device combo Syfovre (pegcetacoplan) has discovered that the culprit is likely the company’s injection kits, not the…

In a brief filed Monday, Amgen and Horizon argue that the U.S. District Court of Northern Illinois shouldn’t let the Federal Trade Commission (FTC) block their union over concerns that…

Intarcia Therapeutics will continue its seven-year quest for FDA approval of its drug-device diabetes treatment with an alternative form of hearing — a public hearing before an advisory committee on…