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Last updated on April 21, 2014 at 5:21 EDT

Latest FDA Stories

2014-04-16 12:29:46

CHESTERFIELD, Mo., April 16, 2014 /PRNewswire/ -- Amid the FDA and ASHP announced shortages of unapproved Neostigmine Methylsulfate Injection; Eclat Pharmaceuticals is effectively ending the shortages with BLOXIVERZ®, the only FDA-approved Neostigmine Methylsulfate Injection. http://photos.prnewswire.com/prnvar/20140416/74458 BLOXIVERZ is available in two dosage strengths, 0.5 mg/mL and 1 mg/mL, in 10 mL multiple dose vials. All other Neostigmine Methylsulfate Injections are not...

2014-04-15 23:15:08

National network of attorneys continues to offer no-cost consultations to consumers over allegations that Lipitor and other statins increase the risk of developing diabetes. San Diego, CA (PRWEB) April 15, 2014 http://www.resource4thepeople.com/defectivedrugs/lipitor-lawsuit.html Resource4thePeople today announced today the scheduling of a key court hearing involving litigation* containing allegations that the anti-cholesterol medication Lipitor may cause patients to develop diabetes....

2014-04-15 23:15:02

The FDA advised consumers on April 11, not to use Infinity because it contains a hidden drug ingredient, sibutramine. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) April 15, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on safety alerts for weight loss products. On April 11, the US FDA advised...

2014-04-15 23:14:13

Beginning on Sept. 24, 2014, a unique device identifier (UDI) must be added to Class III medical devices distributed in the US. Devicemakers need to understand what UDI is, who it applies to, what the exceptions to the rule are, what deadlines must be meet, what UDI issuing agencies are and how to work with them. Falls Church, VA (PRWEB) April 15, 2014 The FDAnews UDI Compliance Kit **FDAnews Publication** http://www.fdanews.com/UDIkit Beginning on Sept. 24, 2014, a unique device...

2014-04-15 12:30:07

Potential U.S. Commercialization in 2014 CHICAGO, April 15, 2014 /PRNewswire/ -- Medac Pharma, Inc., a privately held pharmaceutical company focused on the development of new molecules and improving the effectiveness of existing medicines, announced that the U.S. Food and Drug Administration (FDA) has granted approval for the name Rasuvo(TM) for the company's lead compound, MPI-2505, a subcutaneous injectable methotrexate (MTX) delivered in a ready-to-use autopen. Currently under...

2014-04-15 08:30:55

SAN BRUNO, Calif., April 15, 2014 /PRNewswire/ -- Cord Blood Registry® (CBR®) announces the launch of an FDA-regulated clinical trial being conducted at The University of Texas Health Science Center at Houston to investigate two forms of stem cell therapy in children diagnosed with cerebral palsy. The randomized, placebo-controlled study aims to compare the safety and efficacy of an intravenous infusion of cord blood stem cells to bone marrow stem cells....

2014-04-14 23:12:02

National network of attorneys now offering no-cost consultations in connection with FDA's announcement that safety of testosterone treatments is under review. San Diego, CA (PRWEB) April 14, 2014 http://www.resource4thepeople.com/defectivedrugs/testosteronetreatments-lawsuits.html Resource4thePeople announced today its latest update for consumers who may be considering legal action over concerns about heart attacks and strokes from testosterone treatments as detailed in a recent Food...

2014-04-14 23:10:18

On April 11, the FDA advised consumers not to purchase or use Lite Fit USA as it was confirmed it contained sibutramine. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) April 14, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on safety alerts for medical products including weight loss products. As the...

2014-04-14 23:02:32

As drug and devicemakers well know, the convention floor is a great place to get new customers and make new sales. In the time it takes to hold a staff meeting or have a business lunch, learn how to implement a four-step audit process that teaches how to audit operations before the FDA or an international regulatory body catches a misstep. Falls Church (PRWEB) April 14, 2014 How to Train Your Staff to Spot Promotional Violations **FDAnews Webinar** April 24, 2014 — 1:30 p.m. – 3:00...

2014-04-14 12:37:07

- System converges best capabilities of spatial resolution, temporal resolution, whole organ coverage to enable physicians to diagnose even the most challenging patients WAUKESHA, Wis., April 14, 2014 /PRNewswire/ -- GE Healthcare, a unit of General Electric Company (NYSE: GE), today announced U.S. FDA 510(k) clearance of its Revolution* CT^, which will enable physicians to diagnose even the most challenging patients. This innovative technology provides uncompromised image quality and...