Attorney Stephen McConnell explains how a recent court decision in a glucosamine supplement preemption case can be instructive to drug and medical dev...
FDA approves a GlaxoSmithKline NDA for Jesduvroq (daprodustat) tablet that it describes as the first oral treatment for anemia caused by chronic kidne...
Regulatory consulting firm Greenleaf Health brings onboard two former FDA officials former Office of Compliance Don Ashley and former FDA Europe Offi...
FDA issues an import alert and a safety alert on EzriCare Artificial Tears or Delsam Pharmas Artificial Tears due to potential bacterial contamination...
FDA says the Philips Respironics recall of specified BiPAP and CPAP masks for a safety concern was Class 1
FDA outlines its ongoing strategy to expand access to overdose reversal products that has reached a milestone by having upcoming advisory committee me...
FDA says most postmarketing reports and commitments are generally progessing on schedule, according to the FY 2021 annual report.
The Government Accountability Office says a new HHS program to produce medical countermeasures such as drugs and vaccines should assess challenges and...
