Regulatory Compliance

  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 […]

  Last week, I wrote that Vice President Joe Biden was going to meet with cancer researchers to talk about regulatory questions revolving around precision medicine. Today, we know much more about the cancer “moonshot” President Obama charged Biden with in this week’s State of the Union address. In a post on the publishing platform […]

  We’ve been getting a lot of requests, lately, to help companies decommission their old GxP systems. The systems were once validated and still contain GxP data that might someday need to be reviewed or analyzed, but they’re no longer being actively used. They’re just sitting there, taking up server space, undergoing basic IT maintenance, […]

  According to STAT, Vice President Joe Biden is meeting with over a dozen of the nation’s top cancer researchers today to talk about regulatory questions revolving around precision medicine. As you might recall, Biden’s son, Beau, recently died of brain cancer at the age of 46. 

  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 […]

  Welcome to the New Year! Similar to the way we share our most popular blog posts on a monthly basis, it only makes sense to look back at the most viewed posts from 2015. So, here it goes, with number one being the most read piece. 

  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. 

There was a lot to talk about in 2015, but our most popular posts centered around compliance, security and risk management. Here are your favorite posts of the year:   Ten | How to drive the most value from your compliance investments Compliance is a strategic imperative for financial services organizations. This post discussed how […]

  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 […]

  We recently discussed how Oracle’s safety system has the ability to produce ad hoc descriptive statistical reports on quality data. This brings us to the last rule we’ll discuss in our “Argus Safety for CAPAs” blog series. 

  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. 

  We recently touched on how Argus Safety enables you to track product complaint data and follow it through resolution. Today, we’ll discuss another CAPA rule the safety system supports.