A U.S. Food and Drug Administration (FDA) review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug Xolair (omalizumab) than in those who were not treated with Xolair. As a result, we have added information about these…
FDA Drug Info Rounds Video
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Status of OTC Rulemakings
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Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)
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Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act of 2012 (FDASIA)
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Medical Device Recall: Cobe Spectra Apheresis System Disposable Tubing Sets
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FDA Drug Safety Communication: Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections
Safety AnnouncementAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [09-01-2010] The U.S. Food and Drug Administration (FDA) is reminding healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections. The increased risk…
Summary Basis for Regulatory Action, June 2, 2014
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Drug Master Files for CBER-Regulated Products
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Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines
Draft Guidance for Industry This guidance document is for comment purposes only. The technical specification associated with this guidance is provided in a separate document and is updated periodically. To ensure that you have the most recent version of the technical specifications document, check the CBER ICSR Specifications Web page at: http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/ucm174963.htm Reference Information About…