In the wake of Congress repeatedly trying and failing to pass the bipartisan Verifying Accurate, Leading-edge IVCT (In-Vitro Clinical Test) Development (VALID) Act, the FDA today announced its final rule…

Heightened regulation of mobile health apps and notification requirements for entities not covered under HIPAA are included in the final changes to the FTC’s Health Breach Notification Rule (HBNR) unveiled…

From 2020-2021, more than 10 percent of globally manufactured active pharmaceutical ingredients (API) — 147 compounds — were linked to drug shortages in the US, according to a research letter…

As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws…

A biopsy needle designed for use with a system that helps locate and diagnose brain tumors has been recalled by the manufacturer, Elekta Instrument AB, and is now deemed a…

In this edition of Quick Notes, the FDA has elevated four device recalls to Class I, including an infusion pump that has caused six injuries and one death, two PCB-leaching…

This week, the European Parliament adopted the European Commission’s (EC) proposal to grant more time for companies to come into compliance with 2022’s In Vitro Diagnostic Medical Devices Regulation (IVDR).…

Cardinal Health received an FDA Warning Letter because the company is marketing Monoject convenience kits that include 3 mL, 10 mL, and 20 mL piston syringes and control syringes made…

This week, the FDA announced a Medical Devices Advisory Committee meeting, availability of a report on postmarketing performance of drug firms, revised draft guidance on biologic promotional labeling and advertising,…

Minimizing the number of assessment cycles and communications to get to approval is the goal of an FDA draft guidance on the composition statements needed for NDAs and ANDAs. Source:…