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Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic
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Safety Labeling Changes — Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act
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Postmarketing Studies and Clinical Trials — Implementation of Section 505(O)(3) of the Federal Food, Drug, and Cosmetic Act
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Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies
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Safety Reporting Requirements for INDs and BA/BE Studies- Small Entity Compliance Guide
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Safety Considerations for Product Design to Minimize Medication Errors
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Best Practices in Developing Proprietary Names for Drugs
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FDA Drug Safety Communication: FDA approves label changes for antibacterial Doribax (doripenem) describing increased risk of death for ventilator patients with pneumonia
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FDA Drug Safety Communication: FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products
Safety Announcement [01-31-2014]Â The U.S. Food and Drug Administration (FDA) is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of…