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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 letter referenced the FDA’s list of 128 drugs currently in shortage, including commonly used medications that treat cancer, heart failure, infections and respiratory illnesses. 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