There may not be a worse time to push a new drug through FDA-especially a "me-too" product with a questionable benefit-risk profile. Until Congress releases its grasp on the approval process, FDA isn't taking any chances. Unfortunately for industry, a few drugs are getting caught in the crossfire. Merck seemed unprepared for the new climate with Arcoxia; will other sponsors learn the lesson?
By Kate Rawson
The rejection of Merck & Co. Inc. ’s etoricoxib (Arcoxia) by the Food & Drug Administration should send a very...
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FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user free appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.
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The 14 July deadline for the Citeline Japan Awards 2025 in Tokyo is approaching fast, so here's a reminder to take a look at the categories and criteria and be sure to get your submissions in by this date. Sponsorship opportunities and tables for the event are also available.
