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…

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…

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…

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…

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…

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…

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…

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…

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…

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…