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Last updated on April 16, 2014 at 12:34 EDT

Latest FDA Stories

2014-03-11 23:33:21

This free webinar will discuss how organizations can use Empirica Signal to data-mine the existing FDA Adverse Event Reporting System (FAERS) to determine safety signals. San Mateo, CA (PRWEB) March 11, 2014 Who: Christina Wocosky, principle consultant, safety and pharmacovigilance, BioPharm What: Webinar: "Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting System with Oracle Empirica Signal" Ever since the European Union (EU) introduced new legislation...

2014-03-11 23:30:43

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 11, 2014 The prescription drug safety center DrugNews.net is announcing new information on the site about the blood thinner Pradaxa. A new report shows the Food and Drug Administration of Jordan recently approved the popular drug, marking the 100th country to authorize its use*. DrugNews is a free...

2014-03-11 16:26:25

Once Results of Studies Are Approved by the FDA, the Smaller 50cc SynCardia Heart and New Permanent Use Indication Will Triple the Number of Heart Failure Patients Who Can Get a 2nd Chance at Life TUCSON, Ariz., March 11, 2014 /PRNewswire/ -- Recent developments surrounding the SynCardia temporary Total Artificial Heart will make the life-saving device available to three times the number of people suffering from end-stage biventricular heart failure. Over 300 SynCardia Hearts have...

2014-03-11 16:26:18

Results provide significant support to advance i-FACTOR(TM) Peptide Enhanced Bone Graft for FDA regulatory review. WESTMINSTER, Colo., March 11, 2014 /PRNewswire/ -- Cerapedics, Inc., an orthobiologics company focused on developing and commercializing novel peptide enhanced bone graft products based on its proprietary synthetic small peptide (P-15) technology platform, today presented preliminary outcomes data from a FDA Investigational Device Exemption (IDE) clinical trial for...

2014-03-10 23:25:54

Human Experimentation without informed consent is at the center of a Senate Judicary Committee Investigation of a Prestiguous Academic University, which was reopened after violations of USC 1001 of the Federal Code. Chicago, IL (PRWEB) March 10, 2014 Since 2008, the Honorable Senator Grassley has investigated Northwestern University for allegations surrounding Human Experimentation without Informed consent. According to FDA documents, 667 patients received the non-approved FDA devices...

2014-03-10 23:01:48

With Pradaxa Lawsuit Mounting, A Recently Published Study Indicates The FDA Received More Complaints About The Blood Thinner Pradaxa Than Any Other Prescription Drug Over A Two Year Period Columbus, OH (PRWEB) March 10, 2014 As Pradaxa Lawsuits continue to be filed (MDL 2385), lawyers at Wright & Schulte LLC are reviewing the findings of a recently released study found the blood thinner Pradaxa to be the most complained about prescription drug in the United States. This Pradaxa study...

2014-03-10 08:31:05

ROCKVILLE, Md., March 10, 2014 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) today provided an update on its clinical trials program and reported its 2013 financial results for the year ended December 31, 2013. (Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO) "2013 was an exciting year for advancement in our NSI-566 cell therapy clinical programs," said Karl Johe, PhD, Neuralstem's Chairman of the Board and Chief Scientific Officer. "Our Phase II ALS trial...

2014-03-10 08:30:14

DCVax-L Is First Product of Its Kind to Receive Hospital Exemption from German Regulator BETHESDA, Md., March 10, 2014 /PRNewswire/ -- Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that it has received approval from the Paul Ehrlich Institute ("PEI"- the FDA of Germany) of a "Hospital Exemption" early access program under Section 4b of the German Drug Law. Under this...

2014-03-07 23:25:20

The DrugRisk Center is the largest source on the Web for information on prescription drug research, side effects and legal news. Visit http://www.DrugRisk.com Chicago, IL (PRWEB) March 07, 2014 The prescription drug safety center DrugRisk.com is announcing updated legal news on the site for patients taking the blood thinner Pradaxa. In a new report, lawsuits allege the research institute that conducted trails of Pradaxa for its FDA approval failed to disclose side effects like internal...

2014-03-06 23:28:33

Section 505(b)(2) can provide relatively fast-track approval for a wide range of products, especially for those that represent a limited change from an existing or approved drug. Here's an opportunity to get all the details from a recognized expert. Falls Church, VA (PRWEB) March 06, 2014 Cut Drug Approval Time: Is A 505(b)(2) the Right Way to Go? **FDAnews Webinar** March 25, 2014 — 1:30 p.m. – 3:00 p.m. EDT http:// http://www.fdanews.com/DrugApproval Yes, it is possible to...