Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Serious Cardiovascular EventsJuly 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 CancerJuly 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, 2011July 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...
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.
Potential for inadvertent, increased radiation exposure in patients who underwent or will be undergoing cardiac positron emission tomography (PET) scans
Device spending and prices are not contributing to the rising cost of healthcare.
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, 2011July 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...
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Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic DevicesJuly 12, 2011 9:31 am | by U.S. Food & Drug Administration | News |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...
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 TabletsJune 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.
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 MislabeledJune 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 RecommendationsJune 24, 2011 8:31 am | by U.S. Food & Drug Administration | News | Comments
Increased risks of cardiovascular events using ESAs in this patient population.
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..
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...
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.
This product was NOT distributed in the U.S. The product was only distributed in France on October 5, 2010.
To discuss Industry?s proposals for the next reauthorization, as well as present data on workload issues and discuss additional FDA proposals.
Failure may result in vessel wall injury, increased procedure time and/or emergency surgery to remove the partially deployed stent.
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 â€“ Catheter Tip Can Break Inside of the PatientJune 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.