Manufacturers commenting on an FDA draft guidance addressing electronic data from clinical trials say the guidance is out of sync with current capabilities and practices for data capture and lacks information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 TubesApril 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.
Two lots of topiramate 100mg tablets recalled, reports of temporary gastrointestinal symptoms.
Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young AdultsApril 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.
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 TungstenApril 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.
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 ReactionsApril 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.
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 RecallApril 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 AdhesiveApril 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.
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 HospitalsMarch 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.
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 DMarch 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 SystemMarch 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...
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...
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.
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.
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, CaliforniaMarch 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...
New Warning about serious heart, kidney, or breathing problems which can be fatal.
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.
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 NewbornsMarch 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.