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Big pharma again came out on the losing end of a major court battle challenging the Biden administration’s Inflation Reduction Act (IRA) drug price negotiations, as a New Jersey federal judge Monday rejected legal challenges from Bristol Myers Squibb and Johnson & Johnson. Read More
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 declaring that in vitro diagnostic products (IVD) manufactured in a laboratory are now considered medical devices, and thus under the regulation of the FDA. Read More
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 Friday. Read More
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 published in JAMA Network. Read More
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 and regulations that could impact your business. Read More
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 Class I recall by the FDA for its potential for leaving microscopic steel debris in the brain. Read More
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 brands of dialysis tubing, and an anesthesia machine that might simply shut off if used on battery power. Read More
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). Read More
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 by Chinese manufacturer Jiangsu Shenli Medical Production. Read More
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, three draft guidances on cancer clinical trial eligibility criteria, and a request for comments on promoting effective drug development. Read More
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. Read More
In this edition of Quick Notes, the FDA finally OKs a 40-year-old European mainstay antibiotic for uncomplicated UTIs, an immunotherapy for bladder cancer, a generic form of Narcan nasal spray, and a pediatric version of Lutahera — the first-ever radioligand approved for use in children. Read More