What offices within the Center for Drug Evaluation and Research had input into the decisions?
Participants in the CDER decision-making process included staff from the Office of New Drugs (i.e., the Division of Anti-Inflammatory, Analgesic, and Ophthalmic Drug Products, the Division of Over-the-Counter Drug Products, and the Offices of Drug Evaluation II and V), the Office of Drug Safety, Office of Pharmacoepidemiology and Statistical Science, the Office of Medical Policy, the Office of Regulatory Policy, and the Office of the Center Director. 5. Does the Office of Drug Safety agree with the Office of New Drugs and the Divisions? The management of the Offices of Drug Safety and New Drugs are in full agreement regarding the actions announced by FDA today. 6. Why has FDA requested Pfizer to voluntarily withdraw Bextra from the market? We have concluded that, from a public health perspective, we must assume that Bextra has an increased risk of CV events with long-term use. This conclusion is strongly supported by the significant increase in CV risk seen in those patients who had ju
