Posts Tagged ‘adverse events’

  This is a question most of us hear when picking up prescriptions at a pharmacy. But, have you ever questioned the information the pharmacist gives you? Were his or her answers accurate? Did that information take your personal situation, such as your medical history, into consideration? What’s the source of the information they provide, […]

  A few days ago, I read an article in The Atlantic about precision medicine. But it wasn’t about developing drugs for individuals with specific biomarkers. Instead, it discussed a simpler form of precision medicine that can prevent serious adverse events (SAEs). This method can actually fit in your wallet. It’s a card that houses […]

Since the infamous Kim Kardashian Instagram post went up and the FDA issued a Warning Letter to Duchesnay, the company she was representing, a couple of things have happened. For one, Kim has issued a corrective post (i.e., ad), which outlined the safety information for Diclegis, the medication for morning sickness she is promoting. And, […]

  According to the September/October edition of the Impact Report released by the Tufts Center for the Study of Drug Development (CSDD), the reporting of adverse events (AEs) by healthcare professionals is inadequate. In particular, regulatory submissions are an issue due to the lack of critical information provided on submission forms, which can inadvertently alter […]

  In case you missed the headlines in the last few days, the FDA issued a Warning Letter to Duchesnay over Kim Kardashian’s Instagram post promoting Diclegis, the pharmaceutical company’s drug for “the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management,” commonly known as morning sickness. 

Editorial Credit: Gil C / Shutterstock.com Analyzing Google searches to uncover previously unknown adverse events isn’t news, per se, but it looks like it could be gaining traction with the FDA. According to a recent Bloomberg article, the FDA’s public calendar shows that several employees from Google met with the FDA to discuss the possibility […]

  I just read “Failing To Report Severe Drug Side Effects: A National Embarrassment,” written by Forbes contributor Luke Timmerman. He talks about his recent personal experience with our health system and what he believes is poor adherence to the reporting of adverse events. Why should patients or their loved ones have to demand that […]

  Most of us have searched for information about pharmaceuticals on the web and, more often than not, wound up on a website that provided general information about the product. Such sites are usually sufficient enough to answer basic questions. But, what if there were a site that offered more? What if there were a […]

  Dr. Janet Woodcock, the director of the Center for Drug Evaluation and Research (CDER) at the FDA, recently posted a blog piece that discussed the department’s strides in precision and personalized medicine. She points out that since 2012, CDER has approved 30 targeted therapies, eight of which were in 2014. 

  Now that April 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 March – they’re ranked in order of popularity, with number one being the most viewed piece. 

The pharmaceutical and medical device industries continue to be under close scrutiny by the FDA when it comes to product safety and the reporting of adverse events. With stringent regulatory requirements that’ll make any company or patient cringe, there’s no way to hide from authorities. And, rightly so. But, guess what? There are also adverse […]

Over the years we have seen some general confusion regarding the use of the FDA MedWatch 7-day report for fatal blood collection or transfusion reporting versus the standard 7-day alert requirement for FDA individual case safety reports from IND trials. Some of the safety systems that our company has worked with over the years do […]