The first-ever sepsis diagnostic powered by AI has been granted De Novo marketing authorization by the FDA, addressing a decades-long and expensive challenge for the U.S. healthcare system — rapid…

Three medical devices — radial artery and arterial line catheterization kits, a neurovascular catheter, and gas-powered portable ventilators — have been deemed Class I, the FDA’s most serious type of…

Seeking to get back on track for FDA approval of its first-of-a-kind epinephrine nasal spray, ARS Pharmaceuticals says it has provided the agency with responses to all its additional requests…

President Biden continued to push for extending the prescription drug cost-cutting provisions of the Inflation Reduction Act (IRA) beyond Medicare recipients in a speech broadcast on YouTube on Wednesday. Source:…

Two pharmaceutical giants — AstraZeneca and Eli Lilly — endured 483 knocks recently: AZ for releasing an out-of-spec bilayer tablet and Lilly for lapses in aseptic technique. Source: Drug Industry…

This edition of Quick Notes reviews the FDA’s clearance of Abbott’s hand-held rapid blood test for traumatic brain injury, Eko’s AI-powered stethoscope that can detect low ejection fraction (EF), Beacon’s…

The FDA questioned and answered virtually all aspects of Remote Regulatory Assessments (RRA) in an 18-page revised draft guidance issued last January, and the comments on the Q&A document have…

This edition of Quick Notes reviews the regulatory and/or judicial status of four drugs, including an add-on therapy for a rare blood disorder, a drug to treat forms of pulmonary…

Guest columnists Darius Lakdawalla and Charles Phelps write on the need for a new way to evaluate the value of drugs and therapies. Darius Lakdawalla is the Quintiles Chair in Pharmaceutical…

A corporate culture that values quality management at every level is key to achieving and maintaining high-quality data throughout the life cycle of all in vivo bioavailability (BA) and bioequivalence…