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Last updated on April 17, 2014 at 7:54 EDT

Latest FDA Stories

2014-03-14 23:23:41

Get five days of hands-on, interactive training at FDA Compliance Bootcamp 2014.The course instructors have trained the FDA's own investigators and some are former FDA investigators themselves. Falls Church, VA (PRWEB) March 14, 2014 FDA Compliance Boot Camp 2014: Validation, Data Security, Quality Risk Management and Compliance Training April 7 - 11, 2014 – Frederick, MD http://www.fdanews.com/FDAComplianceBootCamp Imagine getting inside the head of a working FDA inspector and...

2014-03-14 16:22:42

Former FDA Inspectors Train Medical Device, Pharmaceutical Manufacturers How to Prepare for FDA Audits of Computerized Systems, Electronic Records FALLS CHURCH, Va., March 14, 2014 /PRNewswire-iReach/ -- FDA Compliance Boot Camp 2014: Validation, Data Security, Quality Risk Management and Compliance Training April 7 - 11, 2014 - Frederick, MD http://www.fdanews.com/BootCamp2014 (Photo: http://photos.prnewswire.com/prnh/20140314/MN83628) Imagine getting inside the head of a working FDA...

2014-03-13 23:27:39

http://www.DrugNews.net is the web’s premier source for prescription device warnings, research, side effects and legal news. Visit the DrugNews Center today. New York, NY (PRWEB) March 13, 2014 The prescription drug safety center DrugNews.net is announcing updated information on the site for patients taking testosterone replacement therapies, or “low-T” drugs. A recent lawsuit alleges the drug Testim caused a male patient to suffer a stroke*. This comes amid a report that the FDA...

2014-03-13 23:27:22

JDP Therapeutics Inc., a privately held specialty pharmaceutical company, is pleased to announce that the Company’s Investigational New Drug (IND) to conduct an initial Phase 3 clinical trial of JDP-205 in patients with acute urticaria associated with an acute allergic reaction has been cleared by the U.S. Food and Drug Administration (FDA). Blue Bell, PA (PRWEB) March 13, 2014 JDP Therapeutics Inc., a privately held specialty pharmaceutical company, is pleased to announce that the...

2014-03-13 23:22:41

The Foundation for Women’s Cancer applauds the decision made by an expert panel at the FDA yesterday to include HPV testing as part of first-line primary screening for cervical cancer. The combination of the HPV test and the Pap test can reassure women about their screening results, and is especially important for women over 30 who may be able to extend screening intervals based upon these results. Chicago, IL (PRWEB) March 13, 2014 The Foundation for Women’s Cancer applauds the...

2014-03-13 16:27:19

HORSHOLM, Denmark, March 13, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced the U.S. FDA accepted for standard review the company's New Drug Application (NDA) for Envarsus(®) for the prevention of organ rejection in adult kidney transplant patients. Envarsus(®) is Veloxis' once-daily tacrolimus based on the company's proprietary MELTDOSE technology. Key points: -- FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA)...

2014-03-13 08:29:40

People with Inadequate or Not Enough Lashes Can Grow Their Own Lashes with LATISSE® (bimatoprost ophthalmic solution) 0.03%, the only FDA-Approved Treatment for Growing Eyelashes Longer, Fuller and Darker in 16 weeks IRVINE, Calif., March 13, 2014 /PRNewswire/ -- According to a new U.S. survey conducted by Wakefield Research on behalf of Allergan, Inc., maker of BOTOX® Cosmetic (onabotulinumtoxinA), three out of four women (n = 500) have admitted to having concerns about their inadequate...

2014-03-13 08:28:16

Achieved Negative Predictive Value and Sensitivity ~97% and Specificity ~38% CASTLE ROCK, Colo., March 13, 2014 /PRNewswire/ -- Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance for and commercializing its CE Marked APPY1(TM) Test, a rapid, multiple biomarker-based assay for identifying patients that are at low risk for appendicitis, today announced positive top-line results from its pivotal U.S. study. The APPY1 Test performed well,...

2014-03-12 12:29:03

Qudexy(TM) XR Offers Newest Option for Managing Certain Seizure Disorders and Marks the Company's Entrance into the Epilepsy Therapeutic Area MAPLE GROVE, Minn., March 12, 2014 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. (Upsher-Smith), today announced it received approval on March 11, 2014 from the U.S. Food and Drug Administration (FDA) for Qudexy(TM) XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth...

2014-03-12 12:28:46

-- Pilot to be designed and conducted with FDA input, will include broad and diverse industry representation -- TAMPA, Fla., March 12, 2014 /PRNewswire-USNewswire/ -- ISPE announced today that it will conduct the industry's first Quality Metrics Pilot Program designed to define and operationalize standard metrics reporting to the U.S. Food and Drug Administration (FDA). The year-long program will test a series of leading and lagging indicators that will support an FDA risk-based...