Audience: Hospital surgical staff, OB/GYN physicians, other healthcare professionals [UPDATED 07/13/2011] ISSUE: FDA is issuing an update to inform health care providers and patients that serious complications associated with surgical mesh for transvaginal repair of POP (Pelvic organ prolapse) are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. BACKGROUND: The number…
Adverse Event Reporting System (AERS) Statistics
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FDA Drug Safety Communication: Increased radiation exposure due to undetected strontium breakthrough when using CardioGen-82 for cardiac positron emission tomography (PET) scans
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Minutes from Negotiation Meeting on MDUFA III Reauthorization: June 27, 2011
FDA – Industry MDUFA III Reauthorization MeetingJune 27, 2011, 10:15 – 2:30 pmFDA Switzer Building, Washington, DCRoom 1007 Purpose To discuss MDUFA III reauthorization. Participants Meeting Start Time: 10:15 am Industry began with a presentation representing AdvaMed, MITA, and MDMA which provided a response to FDA’s proposal, offered a proposal for a process for mitigating…
Guidance for Industry and FDA Staff
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Center for Devices and Radiological Health Forum for International Medical Device Regulatory Authorities (Advanced Session), September 13-16, 2011
Introduction Date and Location Eligible Participants Registration Contact Us INTRODUCTION The United States Food and Drug Administration (USFDA) Center for Devices and Radiological Health (CDRH) is pleased to announce an advanced session of the CDRH Forum for International Medical Device Regulatory Authorities scheduled for September 13-16, 2011. The CDRH Forum is established for the exchange…
Consumer Information on: Elecsys® Anti-HBc Immunoassay and Elecsys® PreciControl Anti-HBc on the Elecsys® 2010 Immunoassay Analyzer
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Consumer Information on: Elecsys® Anti-HBc Immunoassay and Elecsys® PreciControl Anti-HBc for use on the E170 MODULAR ANALYTICS
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Information on Urogynecologic Surgical Mesh Implants
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