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Latest FDA Stories

2014-06-20 23:01:33

SOPs is the problem cited in 60% of all FDA warning letters due how poorly they're written, communicated, monitored and enforced. Attend Creating Effective SOPs and learn how to write SOPs the easy way thanks to step-by-step, SOP-specific strategies. Falls Church, VA (PRWEB) June 20, 2014 Creating Effective SOPs: How to Turn a Headache Into a Collaborative Success **Presented by FDAnews and David Dills, Regulatory & Compliance Consultant** July 17-18, 2014 – Raleigh, NC...

2014-06-20 23:01:14

With over 100 Testosterone Treatment Lawsuits Pending Litigation, The FDA Continues Its Investigation Into The Potential Health Risks of Testosterone Replacement Therapy Drugs Reports Wright & Schulte LLC Columbus, OH (PRWEB) June 20, 2014 As testosterone treatment lawsuits move forward in federal litigation in Illinois, Wright & Schulte LLC has learned that the U.S. Food & Drug Administration (FDA) is now requiring manufacturers of testosterone therapy products to expand...

2014-06-20 23:00:51

Industry experts Kevin Nelson and Dr. Patrick Gallagher from Duane Morris LLP will use examples from leading companies that are currently attempting to demonstrate biosimilarity. In this session, attendees will learn the specifics of the FDA’s newest recommendations for showing that a proposed product is “highly similar” to a reference product, gain fuller understanding of the impact of the just-released clinical guidance, and get newly-updated ideas and strategies based on the...

2014-06-19 23:11:48

SureClinical is first eClinical application provider to offer integrated digital signing in the cloud from mobile and web with high trust Adobe Digital IDs and integrated workflows, automating manual, paper-based processes to help organizations transform into fully digital paperless businesses. Rancho Cordova, California (PRWEB) June 19, 2014 SureClinical Inc., an industry-leader in collaborative cloud health sciences applications, announced today the SureClinical eTMF Summer ’14...

2014-06-19 23:09:27

On June 18, the FDA published a voluntary recall for one lot of Marcaine (Bupivacaine HCI Injection, USP), 0.5 percent, 30 ML, Single-Dose, Preservative-Free, by Hospira, due to visible particulates. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) June 19, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on...

2014-06-19 23:01:46

Protecting consumers requires the ability to track products. Washington, DC (PRWEB) June 19, 2014 “The promise of personalized medicine will only be achieved when adequate information is available to clinicians to tailor care to the individual and ensure the best health outcomes for all,” said Jane L. Delgado, President and CEO of the National Alliance for Hispanic Health (the Alliance). Citing the “historic and continuing underrepresentation of minorities in clinical trials,” the...

Tablet with a medicine
2014-06-19 10:33:25

Brett Smith for redOrbit.com - Your Universe Online In an attempt to raise awareness about a potential increased risk of suicide tied to antidepressant use, health officials may have made inadvertently made the problem worse. According to a new study in the British Medical Journal, FDA warnings about the increased risk of suicide and subsequent media coverage in 2003 were followed by a sudden drop in the number of prescriptions for antidepressants without compensation through increases...

2014-06-18 23:16:45

On May 28, the FDA announced that the previous recall of certain lots of NaturaLyte Liquid Bicarbonate Concentrate 6.4 liters, by Fresenius Medical Care North America, is classified as Class I. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) June 18, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on...

2014-06-18 23:16:15

Attorneys representing national Androgel testosterone lawsuits at The Onder Law Firm announce the launch of a new website, offering timely news updates, information, and no-cost testosterone lawsuit case review for persons seeking to file an Androgel lawsuit for heart attack or stroke. St. Louis, MO (PRWEB) June 18, 2014 The Androgel Testosterone Lawsuits website is a new resource from national product and family safety attorneys at The Onder Law Firm. Based in St. Louis, these...

2014-06-18 16:26:41

GERMANTOWN, Maryland, and HILDEN, Germany, June 18, 2014 /PRNewswire/ -- - Assay offers faster quantification of CMV DNA levels in patient samples - Up to 60% of all transplant patients are repeatedly tested for CMV viral load to help avoid potentially life-threatening conditions caused by this virus - PMA approval of artus(R) CMV RGQ MDx Kit adds further value to the QIAsymphony modular family of automated instruments as the...


Word of the Day
lambent
  • Licking.
  • Hence Running along or over a surface, as if in the act of licking; flowing over or along; lapping or bathing; softly bright; gleaming.
This word comes the Latin 'lambere,' to lick.
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