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With the House and Senate now in recess until Sept. 9, the FDA is once again facing into a new fiscal year unsure of its funding from Congress. Read More
During the second session of the 118th Congress, FDAnews will track important pending legislation, that has been acted on by Dec. 31, 2023 to keep you updated on laws and regulations that could impact your business. Read More
The FDA has approved Guardant’s Shield blood test for colorectal cancer (CRC) screening in adults aged 45 and older who are at average risk for the disease. 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
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
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