Latest FDA Stories

While FDA Tightens Defibrillator Regulations, AED.com Offers Preemptive Maintenance Against Potential Liability Mishaps

2013-03-29 23:03:37

FDA regulations may cause AED manufactures to undergo more stringent premarket approval processes due to reported failures and recalls. AED.com suggests program to ensure AED readiness. Brentwood, TN (PRWEB) March 29, 2013 The FDA proposed that the seven manufacturers of AEDs or automated external defibrillators need more stringent pre-market approval processes for any AED they manufacture. This proposal does not entertain the idea of mass recalls of automated external defibrillators. Dr....

U.S. FDA Approves INVOKANA(TM) (Canagliflozin) for the Treatment of Adults with Type 2 Diabetes

2013-03-29 16:21:36

INVOKANA(TM) is the first in a new class of type 2 diabetes medications available in the United States RARITAN, N.J., March 29, 2013 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration (FDA) has approved INVOKANA(TM) (canagliflozin) for the treatment of adults with type 2 diabetes. INVOKANA(TM) is the first in a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors to be approved in the United States. It...

Third FDA Clearance for Revolutionary Simbionix Product

2013-03-29 12:22:37

CLEVELAND, March 29, 2013 /PRNewswire/ -- Simbionix USA Corporation, the world's leading provider of medical education and simulation training, has received FDA clearance for its TEVAR (Thoracic Endovascular Aneurysm Repair) application [http://simbionix.com/clinical-rehearsal/library-of-modules/tevar ] for PROcedure Rehearsal Studio(TM) (PRS) [http://simbionix.com/clinical-rehearsal ]. This application joins the family of PRS cleared for marketing applications for...

FDA Cleared ChromaGen Lenses Are A Life-Changing Aid For People Struggling With Dyslexia And Other Reading Problems

2013-03-27 16:27:17

ChromaGen Vision tested 150 students at Brighton School in Baton Rouge Louisiana, a school specializing in dyslexia and dyslexia related learning disabilities. Approximately 72 percent of the students tested were prescribed the ChromaGen lenses and saw an immediate increase in reading speed and accuracy and an improvement in handwriting. KENNETT SQUARE, Pa., March 27, 2013 /PRNewswire/ -- Words that move from left to right or up and down, words that are blurry or come in and out of...

A Must-Attend Gathering of Pharma R&D People Next Month in Shanghai

2013-03-27 08:31:43

-- Conference to bring audiences a chance to practice Quality by Design SHANGHAI, March 27, 2013 /PRNewswire/ -- Quality by Design (QbD) principles are familiar to pharmaceutical companies, and there are many trainings or conferences that focus on the introduction of this idea. However, how to practice these principles and how to make it from idea to implementation is still difficult for them. Based on this background, the Quality by Design 2013 Conference organized by CPhI will be...

Food Sentry Launches Global Food Monitoring Services Site

2013-03-26 23:03:59

After more than a year in development, Food Sentry has launched its subscriber-based web service (http://www.foodsentry.org) to help members identify and avoid foreign and domestic food risks. (PRWEB) March 26, 2013 After more than a year in development, Food Sentry has launched its subscriber-based web service (http://www.foodsentry.org) to help members identify and avoid foreign and domestic food risks. According to a 2013 report by the FDA, over 15% of the food consumed in the United...

Venaxis Advances Pivotal U.S. Study and Accelerates European Market Development for APPY1 Blood-based Appendicitis Test

2013-03-26 16:28:33

Quarterly Update Conference Call and Webcast Today at 4:30 p.m. ET CASTLE ROCK, Colo., March 26, 2013 /PRNewswire/ -- Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance and commercializing its rapid, protein biomarker-based appendicitis test, APPY1, today provided an update on its clinical and commercial activities. The Company continues to enroll patients into its ongoing pivotal U.S. clinical study of APPY1, as well as make...

California, MD Dentist, Dr. Phillip Christie Of Christie Dentistry is Now Trained to Perform the Newest Laser Treatment for Gum Disease with the FDA Cleared Laser

2013-03-25 23:19:45

Dr. Phillip Christie is now trained on the Laser Assisted New Attachment Procedure and offers this modern method of periodontal disease treatment in California, MD. This FDA cleared laser has human histology research showing it is a successful treatment for gum disease, and it is very selective in the type of tissue it eradicates, leaving healthy tissue in the mouth. California, MD (PRWEB) March 25, 2013 Dr. Phillip Christie has joined a growing number of dental professionals who have...

Absorption Systems Registers with FDA as a Generic Drug Facility under GDUFA

2013-03-25 20:21:58

Self-identifies as a Biopharmaceutics Classification System (BCS), Bioequivalence, and Bioavailability Testing Facility EXTON, Pa., March 25, 2013 /PRNewswire/ -- The preclinical contract research organization Absorption Systems, a global leader in pharmacokinetic testing of drugs and the world leader in the in-vitro classification of drugs according to the Biopharmaceutics Classification System (BCS), announces that it has registered with the United States Food and Drug...

Defibrillator Danger: FDA Recommends New Safety, Efficiency Regulations

2013-03-25 13:30:07

Brett Smith for redOrbit.com - Your Universe Online Although they have been credited with saving thousands of lives, the US Food and Drug Administration (FDA) has recommended new regulations for automated external defibrillators (AED), including the requirement that the devices must meet federal approval before hitting the market. "[The] FDA is not questioning the clinical utility of AEDs," said FDA spokesman Dr. William Maisel in a statement on Friday. "These devices are critically...