FDA Drug Safety Communication: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease

  Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [6-16-2011] The U.S. Food and Drug Administration (FDA) is notifying the public that the smoking cessation aid Chantix (varenicline) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information…

Class I Medical Device Recall: Churchill Medical (Vygon) Skin Prep Wipes

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Indomethacin for Injection: Recall of One Lot

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Actos (pioglitazone): Ongoing Safety Review

[UPDATED 06/15/2011] Use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include…

FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary References   Safety Announcement [6-15-2011] The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be…

Standard Operating Procedure for Notice to Industry Letters

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Initial Results of 510(k) Audit

June 15, 2011Center for Devices and Radiological HealthU.S. Food and Drug Administration As part of the 510(k) Action Plan published in January 2011, the Center for Devices and Radiological Health (CDRH) committed to post initial results of an audit of the 510(k) program to the FDA website. This initial analysis focuses only on 510(k) submissions…

Draft Guidance for Industry and FDA Staff – Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of methicillin

DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.Document issued on: June 15, 2011 You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management…