Archive for July 2024

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 of serious skin injuries. Source: Drug Industry Daily

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 spine navigation and robotic-assistance device. Source: Drug Industry Daily

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 presenter was David Chesney, a former director of the FDA’s San Francisco District Office who is now principal and general manager of DL Chesney Consulting.…

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 risk information about the drug. Source: Drug Industry Daily

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 Industry Daily

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 platform for use in operating rooms and a software update for ultra-low field brain images. Source: Drug Industry Daily

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 safety. Source: Drug Industry Daily

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 and regulations that could impact your business. Source: Drug Industry Daily

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 its IVF and ART business. Source: Drug Industry Daily