FDA Drug Safety Communication: Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhythms with high doses

This update provides additional information related to a previous FDA Drug Safety Communication (posted 8/24/2011): Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide). Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary  Safety Announcement [3-28-2012] The U.S. Food and Drug Administration (FDA) is clarifying dosing and warning recommendations for the antidepressant…

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (May 10-11, 2012)

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY:  Food and Drug Administration, HHS. ACTION:  Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA).  The meeting…

Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (May 24, 2012)

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration   [Docket No. FDA-2011-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY:  Food and Drug Administration, HHS. ACTION:  Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA).  The meeting…

Celexa (citalopram hydrobromide)

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Guidance: Class II Special Controls Guidance Document: Full Field Digital Mammography System

Document issued on: March 27, 2012 For questions regarding this document contact Mary Pastel (OIVD) at 301-796-6887 or by e-mail at [email protected] or Kyle J. Myers (OSEL) at 301-796-2533 or by e-mail at [email protected]. This document supersedes “Class II Special Controls Guidance Document: Full-Field Digital Mammography System,” issued November 5, 2010.  U.S. Department of Health and…

New FDA guidance on considerations used in device approval, de novo decisions

FDA NEWS RELEASE For Immediate Release: March 27, 2012Media Inquiries: Michelle Bolek, 301-796-2973, [email protected] Inquiries: 888-INFO-FDA New FDA guidance on considerations used in device approval, de novo decisionsClinical data, risks, benefits and patient risk tolerance outlined in process The U.S. Food and Drug Administration today published a first-of-a-kind guidance for medical device manufacturers, describing how…

CDRH Learn (New Module

Listed below are the courses CDRH currently offers. Additional online courses are being developed and will be posted upon completion. Course List Overview of Regulatory Requirements: Medical Devices [Updated! 11/29/2011] Guidance Documents and Standard Operating Procedures (SOPs) [New! 12/27/2011] Premarket Notification Process – 510(k) Investigational Device Exemption Process – IDE [Updated! 2/23/2012] Bioresearch Monitoring (BIMO)…

WinRho SDF Liquid

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Argatroban Injection 50 mg/50 mL (1 mg/mL): Recall

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