The FDA issued six Warning Letters — to sellers including Amazon and Walmart — and created a drug safety page concerning sales of chemical skin peel products due to risk…
In this edition of Quick Notes, Abbott’s correction for Freestyle Libre 3 sensors, a new FDA webpage for LDTs, 510(k) clearance for Imperative Care catheters and eCential Robotics’ clearance for…
This Q and A is from the management report titled “Managing Data and Documentation for FDA Inspections and Remote Assessments,” based on a webinar from FDAnews, A WCG Company. The…
Kaleo received an “untitled letter” from the FDA Office of Prescription Drug Promotion (OPDP) because one of the company’s social media posts for Auvi-Q (epinephrine injection) does not include any…
The FDA has posted six user fee schedules for FY 2025 on the Federal Register showing increases of up to 44 percent — the highest being for biosimilars. Source: Drug…
This edition of Quick Notes includes FDA clearance for a Signum Surgical anal fistula treatment, a CE Mark for a Roche CGM system, 510(k) clearance of an augmented reality technology…
FDA recently added resources for the 2023 guidance “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” to its Guidance Snapshot Pilot Program webpage. Source: Drug Industry Daily
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has declined to recommend approval of Eisai’s Leqembi (lecanemab) for treatment of early Alzheimer’s disease, citing concerns over the drug’s…
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Dec. 31, 2023 to keep you updated on laws…
This edition of Quick Notes features announcements of Lilly’s acquisition of Morphic, a licensing agreement between SK Biopharmaceuticals and Full-Life Technologies, Agilent’s purchase of Biovectra and Cook Technologies sale of…