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The Senate Finance Committee voted 26-0 in favor of the Better Mental Health Care, Lower Drug Cost and Extenders Act which addresses pharmacy benefit manager (PBM) practices that sponsors Sen. Ron Wyden (D.-Ore.) and Sen. Mike Crapo (R.- Idaho) say drive up the cost of drugs. Read More
The FDA’s proposed transformation of the Office of Regulatory Affairs (ORA) will not only see the office transfer all compliance functions to product centers but could also lead to more efficient inspection planning and execution as well as more effective and timelier regulatory compliance actions. Read More
The FDA has extended the effective date of the guidance “COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers” until Aug. 7, 2024, unless a revised final guidance is issued before that date. Read More
The FDA has deemed as class I the company’s recall of certain Teleflex and Arrow International Pressure Injectable Catheter Kits for a mislabeling issue and Nurse Assist has recalled certain lots of irrigation water for a lack of sterility assurance. Read More
Attorneys general from 24 states and Washington, D.C. have sent the FDA a letter urging the agency to strengthen guidance and provide clear warning labels regarding incorrect pulse oximeter readings for patients of color. Read More
Upcoming events in the coming weeks and months include two FDA advisory committee meetings, MAGI 2024: The Clinical Research Conference as well as webinars on choosing the right IRB review partner, medical device cybersecurity and overcoming common clinical trial challenges. Read More
This edition of Quick Notes highlights the outcome of an adcomm on a device to eliminate cancer cells from blood collected during surgery, the FDA’s acceptance of a medical device cybersecurity consensus standard, and two post-market studies of cardiac device efficacy.Read More
The FDA’s final guidance on real-time oncology review (RTOR) — a program intended to facilitate review of NDAs — advises sponsors to submit in modules, at different times, enabling an earlier start to the application review process. Read More
Intarcia Therapeutics has alleged that the FDA presented “false and misleading” claims about its product and has appealed an FDA advisory committee opinion rejecting its new drug application for ITCA 650 (exenatide in DUROS device), a diabetes drug-device combination. Read More
In a proposed rule on technical changes to the Medicare program, CMS said it wants to permit biosimilar biologic products to be substituted for the reference product, even if the FDA has not yet deemed the biosimilar to be interchangeable. Read More
Ten major pharmaceutical companies will be receiving letters from the FTC challenging the accuracy or proper listing of more than 100 patents listed in the FDA’s Orange Book, which catalogs approved drugs with therapeutic equivalence evaluations. Read More