Tag: FDA
FDA Issues Sterility Correction for Alcohol Prep Pads in Cardinal Health Convenience Kits
The FDA has issued a correction notice for Cardinal Health Webcol Large Alcohol Prep Pads in custom convenience kits manufactured…
Only 29% of FDA orphan drug approvals receive matching EMA authorisation
A 13-year analysis of 814 FDA orphan drug approvals found that only 29% received matching EMA authorisation with orphan status,…
FDA launches pilot programme to accelerate early-stage clinical trials amid global competition
The US FDA is launching a pilot programme to expedite the approval of early-stage clinical trials, citing international competitive pressures…
FDA Restricts Sunscreen Ingredient as Rural Dialysis Clinics Face Closure Crisis
The FDA restricts sunscreen ingredients whilst rural dialysis clinics in Nebraska face closure, revealing competing priorities in US preventive health…
FDA Advisory Panel Endorses Moderna mRNA Flu Vaccine After Earlier Controversy
The FDA's Vaccines and Related Biological Products Advisory Committee endorsed Moderna's seasonal mRNA influenza vaccine in June 2026, resolving the…
UK and US Regulators Launch Joint Liaison Programme to Strengthen Drug Approval Coordination
The UK Medicines and Healthcare products Regulatory Agency (MHRA) and US Food and Drug Administration (FDA) have launched a formal…
FDA alerts healthcare providers to critical shortage of stereotactic breast biopsy needles
The FDA has formally notified healthcare providers of a supply disruption affecting stereotactic breast biopsy needles (product code KNW), a…
Draeger Anesthesia Workstations Under Correction for Ventilator Failure Risk
Draeger, Inc. has issued a correction for Atlan A350 and A350XL anesthesia workstations due to a manufacturing defect that may…