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eSource Guidance Doesn & #8217;t Reflect Current Practice, Industry Says

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

Manufacturers commenting on an FDA draft guidance addressing electronic data from clinical trials say the guidance is out of sync with current capabilities and practices for data capture and lacks information about the sponsor’s role in reviewing data.

Lansoprazole Delayed-Release Orally Disintegrating Tablets by Teva Pharmaceuticals: Letter to Healthcare Professionals - Clogged, Blocked Oral Syringes and Feeding Tubes

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

Tablets may not fully disintegrate when water is added, and/or they may disintegrate but later form clumps which can adhere to the inside walls of oral syringes and feeding tubes.

Topamax (topiramate): Recall - Musty Odor

April 15, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

Two lots of topiramate 100mg tablets recalled, reports of temporary gastrointestinal symptoms.

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Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults

April 14, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

FDA continues to receive reports of a rare cancer of white blood cells.

Penumbra Coil 400 by Penumbra Inc.: Class 1 Recall - Premature Detachment of the Coil(2)

April 13, 2011 3:31 pm | by U.S. Food & Drug Administration | News | Comments

Premature detachment of the coil may cause the coil to unintentionally migrate. This can lead to serious injury including blood clots and stroke.

Axxent FlexiShield Mini by iCAD (formerly Xoft Inc.): Recall- Product May Shed Particles of Tungsten

April 13, 2011 2:30 pm | by U.S. Food & Drug Administration | News | Comments

After use for IORT in breast tissue, these particles can be mistaken for suspicious calcifications during follow up X-rays or scans.

Benzocaine Topical Products: Sprays, Gels and Liquids: Risk of Methemoglobinemia

April 7, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

FDA continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products.

Yervoy (ipilimumab): Risk Evaluation and Mitigation Strategy (REMS) - Severe Immune-Mediated Adverse Reactions

April 6, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

The most common severe reactions include enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy.

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Best Enhancer: Recall – Undeclared Drug Ingredient

April 5, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments

Products marketed as dietary supplements contain undeclared analogue of sildenafil, a drug which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.

Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F by Millar Instruments Inc.: Class 1 Recall

April 1, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments

Small particles (debris) may be found inside the catheter and potentially travel (embolize) from the catheter to tissues, blood vessels, limbs and organs which can result in serious injury and /or death.

Heartstring II Proximal Seal System (HS-1045) by Maquet Cardiovascular, LLC: Recall - Insufficient Adhesive

April 1, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

The deployment tube may detach during use and may result in the failure of the product to operate, This may cause serious injury and/or death.

Consumer Information on: Medtronic & #xae; InterStim & #xae; Therapy System - P080025

March 31, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

The InterStim® Therapy System is a surgically implanted device used to help a patient reduce the number of bowel accidents (fecal incontinence)2. The InterStim® Therapy System has several components: a neurostimulator which delivers an electrical pulse...

Meds IV Pharmacy, IV Compounded Products Recall: Outbreak of Serratia Marcescens Bacteremia in Alabama Hospitals

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

Use of contaminated products may lead to bacterial infection of the blood.

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X-Hero and Male Enhancer: Recall - Undeclared Drug Ingredient

March 29, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

Products marketed as dietary supplement contain drug ingredients sulfosildenafil or tadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.

Soladek Vitamin Solution: Unapproved Product May Contain Dangerously High Levels of Vitamins A and D

March 29, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments

Reports of consumers experiencing decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting, and diarrhea.

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System

March 23, 2011 8:30 am | by U.S. Food & Drug Administration | News | Comments

This document was developed as a special controls guidance to support the classification of ovarian adnexal mass assessment score test system into class II (special controls). An ovarian adnexal mass assessment score test system measures one or more...

Town Hall Discussion With the Director of CDRH and Other Senior Center Management, May 5, 2011

March 14, 2011 11:31 am | by U.S. Food & Drug Administration | News | Comments

The objective of this public meeting is to present the CDRH FY 2010 Priorities. In addition, FDA is interested in engaging in discussions about issues that are of importance to the medical device community. CDRH wishes to obtain feedback/ideas for...

Class I, II Devicemakers Must Continue Malfunction Reports

March 11, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Manufacturers and importers of all devices must continue to submit malfunction reports as they await a promised easing of requirements for Class I devices and Class II devices that are not permanently implantable, life supporting or life sustaining.

Senate Clears Patent Reform Bill in Victory for Devicemakers

March 11, 2011 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Device manufacturers have won a victory in Congress now that the Senate has passed patent-reform legislation that includes several provisions favorable to the industry.

FDA eSubmitter (Radiation Safety Report Video Tutorial and Updated User Guide)

March 11, 2011 9:30 am | by U.S. Food & Drug Administration | News | Comments

The Food and Drug Administration?s eSubmitter tool is part of an electronic submissions program that originated in the Center for Devices and Radiological Health (CDRH). The eSubmitter program is the result of two successful pilot programs at CDRH named..

FDA Safety Notification: Mammography Problems at Huntington Radiology in Huntington Park, California

March 10, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

The FDA became aware of problems associated with the quality of mammograms performed at the Huntington Radiology facility, located at the following address...

Kaletra (lopinavir/ritonavir): Label Change - Serious Health Problems in Premature Babies

March 8, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

New Warning about serious heart, kidney, or breathing problems which can be fatal.

Manufacturer Gets GMP Warning on Sexual Assault, Blood Alcohol Kits

March 4, 2011 1:30 pm | by U.S. Food & Drug Administration | News | Comments

Lynn Peavey, a manufacturer of sexual assault evidence and blood alcohol collection kits, has received a GMP warning for several issues, such as lack of procedures for incoming product inspections and lack of verification activities.

C. Difficile Guidance May Be Difficult to Adopt

March 4, 2011 1:30 pm | by U.S. Food & Drug Administration | News | Comments

U.S. devicemakers may have difficulty obtaining a virus strain that the FDA suggests using to conduct reactivity tests for new products to detect Clostridium difficile infections.

Topamax (topiramate): Label Change - Risk For Development of Cleft Lip and/or Cleft Palate in Newborns

March 4, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

Increased risk of oral clefts in infants born to women treated with Topamax (topiramate) during pregnancy.

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