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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 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
The FDA smacked Natco Pharma for contamination problems and quality control lapses following an inspection of its Rangareddy, Telangana, India facility from Oct. 9 to 18. Read More
With the looming expiration of temporary government funding on Nov. 17, lawmakers face significant challenges to reconciling the House and Senate versions of fiscal 2024 appropriations bills — including one to fund the FDA. Read More
CBER intends to use feedback from the campaign to plan such future activities as workshops, internal CBER research initiatives, training activities, or strategic planning. Read More