Posts Tagged ‘FDA’

  Several days ago, I wrote about how the life sciences industry, including government organizations, is struggling when it comes to the reporting of clinical trial results to the ClinicalTrials.gov database. Unfortunately, other issues plague the industry, including one that The New York Times reported on January 14, 2016. The Government Accountability Office (GAO) found […]

  The life sciences industry could learn a little something from Southwest Airlines’ “Transfarency” campaign, in terms of reporting clinical trial results. A recent investigation by the publication STAT found significant violations in the reporting of clinical trial results to the ClinicalTrials.gov database. Most academic research institutions, drug companies, and even the National Institutes of […]

  An interesting thing happened in pharma and investing. It involved Regeneron and their July 24, 2015 FDA-approved cholesterol drug, Praluent. Forbes outlined the situation, which caused Regeneron stock to drop significantly, in a January 6, 2016 article. According to Matthew Herper, a Forbes columnist, investors got a hold of data from the FDA’s Adverse […]

  According to Dr. Stephen M. Ostroff, FDA Acting Commissioner, and Dr. John K. Jenkins, Director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research, over 40 novel drugs were approved in 2015. The FDA’s website indicates the exact number as 45, which is slightly higher than the previous year and […]

  On December 17, 2015, the FDA issued a warning letter to Sun Pharmaceuticals Industries Ltd. in Gujarat, India. Sun Pharma’s website boasts that it is the “World’s 5th Largest Specialty Generic Pharmaceutical Company” with over 2,000 products in more than 150 markets across the globe. When an organization that large winds up with a […]

  Now that January is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in December – they’re ranked in order of popularity, with number one being the most viewed piece. 

  Demographics in clinical trials have always been scrutinized by the medical community and the public. Are various races, ethnicities, sexes, and ages fairly represented in trials? Does one segment respond better or worse than another to a particular treatment? These questions and more are being answered in Drug Trials Snapshots, a section of the […]

  This is bizarre. It turns out that many doctors don’t know what the real, FDA-approved indications are for the medications they’re prescribing. In a Wall Street Journal article that discusses the risks of off-label uses for prescription drugs, the author cites a 2009 study of 1,199 physicians (mostly primary care doctors and psychiatrists) that […]

  For several years, the FDA has been the center of scrutiny for not having an official social media policy available on its website. According to the Union of Concerned Scientists, the FDA was the only one of 17 government agencies not to have social media policy…until now. 

  Now that December is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in November – they’re ranked in order of popularity, with number one being the most viewed piece. 

  Over the last decade, the life sciences industry has gone from running clinical trials on paper or, in many cases, in Excel, to leveraging comprehensive web-based systems, such as electronic data capture (EDC) and clinical trial management systems (CTMS). But, in more recent years, the widespread use of mobile technology has enabled even more […]

  Megan Thielking from Stat News reports that a scientific journal took a close look at the impact nutritional supplements are having on U.S. military personnel. According to the article, 75% of people in the U.S. military take some type of dietary supplement every month. Since dietary supplements, such as weight-loss pills and multivitamins, don’t […]