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FDA requires label changes to warn of rare but serious neurologic problems after epidural corticosteroid injections for pain
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September 20, 2010: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
Agenda The committee will discuss new drug application (NDA) 22–512, dabigatran etexilate mesylate capsules, sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed indication of prevention of stroke in patients with atrial fibrillation (abnormally rapid contractions of the atria, the upper chambers of the heart). Meeting Materials FDA intends to make background material available to…
Comunicado de la FDA sobre la seguridad de los medicamentos: la FDA aclara el uso pediátrico de Revatio (sildenafil) para la hipertensión arterial pulmonar
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FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension
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Opioid Patient-Prescriber Agreement
A Tool for Shared Decision-Making in the Treatment of Pain As part of a pain treatment regimen, patients may be prescribed opioid analgesics. Opioids, like all drugs, have risks. Prescribing errors and inappropriate use of opioid analgesics increase risk and can lead to serious harm, including death. This harm is preventable. In April 2011, FDA Safe…
FDA approves label changes for antibacterial Doribax (doripenem) describing increased risk of death for ventilator patients with pneumonia
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FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files
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How to Report a Shortage or Supply Issue
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Small Business and Industry Education Series
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