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A Baxter Healthcare drug manufacturing plant in Marion, N.C., has been hit with another Form 483 after an FDA inspection early in the year revealed more deficiencies, including two that remain unresolved from prior inspections. Read More
Immediately after the FDA rejected Novartis’s 2022 citizen petition for the agency to refrain from approving generic versions of its cardiac drug Entresto (sacubitril and valsartan), the company has filed a lawsuit against the FDA for approval of a generic version. Read More
Manufacturers of drugs, biologics and medical devices should be harnessing real-world data (RWD) at the postmarket stage, not just to support regulatory compliance but to generate ideas for innovative new products or indications, according to a former FDA official. Read More
Wayne Pines, senior director at APCO Worldwide, a former associate commissioner of the FDA, and a member of the FDAnews Editorial Board, provides his perspective on the likely direction of health product policies after the presidential election in November. Read More
AMCO International Manufacturing & Design received an FDA Warning Letter because automated external defibrillator (AED) replacement batteries made by the firm have not received FDA approval. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More