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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
Citing price controls on pharmaceutical companies and an increased reliance on offshore manufacturers, Republican leaders of the House Committee on Oversight & Accountability Friday have requested extensive documentation on the FDA’s actions to address the current drug shortage by the end of next week. Read More
The FDA published a pair of final guidances Friday meant to assist drugmakers by providing technical specifications for submitting general clinical outcome assessment (COA) data and patient-reported outcome (PRO) data collected from cancer studies, respectively. Read More
The FDA wants its Radiological Devices Advisory Panel to weigh in on whether irradiators used to prevent metastasis in salvaged blood during cancer surgeries are safe enough to be classified as Class II devices or whether, as the FDA proposes, they should be designated as high-risk Class III devices requiring premarket approval. Read More
The European Commission’s (EC) proposals to reduce a component of intellectual property protection for breakthrough medicines will hasten a trend which has seen Europe’s position as a global innovator deteriorate further in comparison to the U.S., China and Japan, according to a new study. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More