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Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Serious Cardiovascular Events

July 21, 2011 6:30 pm | by U.S. Food & Drug Administration | News | Comments

FDA reviewing data from a clinical trial.

Oral Osteoporosis Drugs (bisphosphonates): Drug Safety Communication - Potential Increased Risk of Esophageal Cancer

July 21, 2011 9:31 am | by U.S. Food & Drug Administration | News | Comments

FDA is reviewing data from published studies to evaluate risk of cancer of the esophagus.

Unique Device Identification (UDI) for Postmarket Surveillance and Enforcement Public Workshop, September 12-13, 2011

July 21, 2011 5:31 am | by U.S. Food & Drug Administration | News | Comments

The Food and Drug Administration is holding a public workshop on the adoption, implementation, and use of unique device identifiers (UDIs) in various health-related electronic data systems. The purpose of this workshop is to engage multiple...

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Information on Mobile Medical Applications

July 19, 2011 5:34 am | by U.S. Food & Drug Administration | News | Comments

Mobile applications are software programs that run on smartphones and other mobile communications devices. Development of mobile medical applications is opening new and innovative ways for technology to improve health and health care.

CardioGen-82 PET Scan: Drug Safety Communication - Increased Radiation Exposure

July 18, 2011 9:32 pm | by U.S. Food & Drug Administration | News | Comments

Potential for inadvertent, increased radiation exposure in patients who underwent or will be undergoing cardiac positron emission tomography (PET) scans

AdvaMed: Device Spending Small Part of Health Expenses

July 15, 2011 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Device spending and prices are not contributing to the rising cost of healthcare.

Medtronic & #8217;s Sales Could Suffer as InFuse Scandal Develops

July 15, 2011 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Sales for Medtronic’s InFuse device are expected to plummet following more allegations that physicians guiding clinical trials covered up adverse events associated with the product.

Town Hall Discussion With the Director of CDRH and Other Senior Center Management, September 22, 2011

July 15, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

In 2010, CDRH held three Town Hall meetings in Minneapolis, Boston, and Los Angeles to provide the public with a new venue to discuss issues of interest with the Center. Due to positive feedback, we planed three more this year. In March 2011, the...

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Information on Urogynecologic Surgical Mesh Implants

July 14, 2011 6:31 am | by U.S. Food & Drug Administration | News | Comments

Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material.

Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices

July 12, 2011 9:31 am | by U.S. Food & Drug Administration | News | Comments

This guidance is intended to assist (1) sponsors who are planning to develop a therapeutic product that depends on the use of an in vitro companion diagnostic device (or test) for its safe and effective use and (2) sponsors planning to develop an in...

Tamiflu (oseltamivir phosphate) for Oral Suspension: Label Change-New Concentration (6 mg/mL)

July 11, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

Patients may potentially receive either concentration (6 mg/mL or 12 mg/mL) from their pharmacy during the next influenza season (2011-2012).

Valproate Products: Drug Safety Communication - Risk of Impaired Cognitive Development in Children Exposed In Utero (During Pregnancy)

June 30, 2011 11:30 am | by U.S. Food & Drug Administration | News | Comments

Benefits and risks of valproate sodium and related products should be carefully weighed when prescribing these drugs to women of childbearing age.

Endocet (Oxycodone / Acetaminophen) Tablets, ( 10mg, 325mg ) : Recall - Some Bottles Contain Different Strength Tablets

June 27, 2011 9:30 am | by U.S. Food & Drug Administration | News | Comments

Risk of increase of acetaminophen dose, which may result in liver toxicity, especially in patients on other acetaminophen containing medications.

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Nature Relief Instant Wart and Mole Remover: Recall - Risk of Severe Skin Burns

June 27, 2011 9:30 am | by U.S. Food & Drug Administration | News | Comments

Active ingredient calcium oxide can cause severe burns, particularly to areas of thin or sensitive skin such as the face, around the eyes, and genitalia.

Butalbital, Acetaminophen, and Caffeine Tablets (USP 50mg, 325mg, 40mg) and Hydrocodone Bitartrate and Acetaminophen Tablets (USP 7.5mg, 500mg): Recall - Bottle Mislabeled

June 27, 2011 8:30 am | by U.S. Food & Drug Administration | News | Comments

Recalled bottles may contain incorrect tablets, patients may unintentionally take butalbital and caffeine instead of hydrocodone.

Erythropoiesis-Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication - Modified Dosing Recommendations

June 24, 2011 8:31 am | by U.S. Food & Drug Administration | News | Comments

Increased risks of cardiovascular events using ESAs in this patient population.

Update on the Safety of Silicone Gel-Filled Breast Implants - Executive Summary

June 23, 2011 6:34 am | by U.S. Food & Drug Administration | News | Comments

Breast implants are medical devices that are used to augment breast size or to reconstruct the breast following mastectomy or to correct a congenital abnormality. Breast implants consist of a silicone outer shell and a filler (most commonly silicone gel..

Anaplastic Large Cell Lymphoma (ALCL) - Videos Added

June 23, 2011 6:34 am | by U.S. Food & Drug Administration | News | Comments

The FDA has identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin?s lymphoma. ALCL is not cancer of the breast tissue. The FDA believes that women with breast...

Risperdal (risperidone) and Risperidone: Recall - Uncharacteristic Odor

June 20, 2011 9:30 am | by U.S. Food & Drug Administration | News | Comments

Two lots recalled. Contamination thought to be the result of a chemical preservative applied to wood used in the construction of pallets on which materials are transported and stored.

Class I Medical Device Recall: Roche Diagnostics Operations, ACCU-CHEK Performa Strip

June 20, 2011 5:31 am | by U.S. Food & Drug Administration | News | Comments

This product was NOT distributed in the U.S. The product was only distributed in France on October 5, 2010.

Minutes from Negotiation Meeting on MDUFA III Reauthorization: June 1, 2011

June 20, 2011 5:30 am | by U.S. Food & Drug Administration | News | Comments

To discuss Industry?s proposals for the next reauthorization, as well as present data on workload issues and discuss additional FDA proposals.

Boston Scientific Innova Self-Expanding Stent System: Recall - Failure to Deploy(2)

June 17, 2011 11:31 am | by U.S. Food & Drug Administration | News | Comments

Failure may result in vessel wall injury, increased procedure time and/or emergency surgery to remove the partially deployed stent.

Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events

June 16, 2011 12:30 pm | by U.S. Food & Drug Administration | News | Comments

Results of a randomized, double-blind, placebo-controlled clinical trial of 700 smokers reviewed.

Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of methicillin-resistant Staphylococc...

June 15, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

FDA is issuing this draft guidance to provide industry and agency staff with recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices (IVDs) intended for the detection of methicillin-resistant...

Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters: Recall – Catheter Tip Can Break Inside of the Patient

June 14, 2011 10:30 am | by U.S. Food & Drug Administration | News | Comments

Risk of embolization causing tissue and blood vessel injury, heart attack or other serious events.

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