Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary References  here.  Although the exact mechanism of this drug interaction is unknown, linezolid inhibits the action of monoamine oxidase A—an enzyme responsible for breaking down serotonin in the brain. It is believed that when linezolid is given to patients taking serotonergic psychiatric medications,…
Guidance for Industry and FDA Staff
Document issued on: July 26, 2011 For questions regarding this document contact Ann H. Costello Ph.D., D.M.D . at 301-796-6493 or by email at [email protected]. U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health Office of Device EvaluationDivision of Ophthalmic, Neurological and Ear, Nose and Throat DevicesNeurodiagnostic and Neurotherapeutic…
Guidance for Industry and FDA Staff
DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: July 27, 2011 For questions regarding the use or interpretation of this guidance in the review of submissions to the Center for Devices and Radiological Health, contact Michael J. Ryan at 301-796-6283 or by email at [email protected]. For questions regarding…
CDRH Learn: BIMO Part 5b
Listed below are the courses CDRH currently offers in Spanish. Additional online courses are being developed and will be posted upon completion. Course List Quality System Regulation 21 CFR Part 820 Basic Introduction Export Certificates for Medical Devices Overview of the Premarket Notification Process – 510(k) [New! 5/18] Bioresearch Monitoring (BIMO) [New! 7/25] Medical Device…
FDA Drug Safety Communication: Chantix (varenicline) drug label now contains updated efficacy and safety information
The following announcement is related to planned labeling changes that were described in the recent FDA Drug Safety Communication on Chantix (varenicline) issued on 6/16/2011. [7-22-2011] The U.S. Food and Drug Administration (FDA) has approved an updated drug label for the smoking cessation aid Chantix (varenicline) to include information about the efficacy and safety of…
Havrix
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Oral Osteoporosis Drugs (bisphosphonates): Drug Safety Communication
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Multaq (dronedarone): Drug Safety Communication
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Inactive Ingredients Database Download
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FDA Drug Safety Communication: Ongoing safety review of oral osteoporosis drugs (bisphosphonates) and potential increased risk of esophageal cancer
 Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary  Safety Announcement [07-21-2011] The U.S. Food and Drug Administration (FDA) is continuing to review data from published studies to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus (esophageal cancer). There have been conflicting…