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Aggregate Report Preparation In Safety And Pharmacovigilance

Aggregate report preparation represents one of the single most time- and resource-intensive pharmacovigilance regulatory requirements, which is why many companies are interested in more automated solutions that are fit-for-purpose. What we typically recommend to clients is a focused approach that optimizes as much as their internal workflow as possible. We also recommend that subject matter […]

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Top 5 Pharma & Medical Device Blog Posts From June 2017

Now that July 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 June – they’re ranked in order of popularity, with number one being the most viewed piece. What Exactly Is An “Adverse […]

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[This Week] Mining The Internet For Safety Signals

Online communities and social networks like Twitter and Facebook have become important real-world data repositories that can be leveraged by life sciences organizations to gain insight into the patient experience, as well as to identify potential safety issues related to drugs and devices – otherwise known as safety signal detection. This week, my colleague, Dr. […]

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Will We See More Advertising From Pharma On Facebook?

Bayer recently launched its first Facebook ad. The ad also happens to be the first time Facebook has allowed a company to put important safety information (ISI) in a scrolling format, something that pharmaceutical companies have long been able to do in banner ads. In addition, the social media giant is also enabling drug companies […]

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FDA Director: We’re Watching How You Manage Product Complaints

We frequently blog about FDA Warning Letters and other regulatory and compliance issues that revolve around traditional pharmaceuticals and medical devices. However, one product segment that we haven’t yet discussed is digital health. This is because digital health products are fairly new to the market and most are still trying to figure out how FDA […]

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The Next Best Thing To A Private Demo Of Argus Safety 8.x

Bring out the popcorn! This Thursday, Dr. Rodney Lemery, one of our experts in drug safety and pharmacovigilance, will be delivering a webinar on the latest version of Oracle Argus Safety, the most widely used and trusted PV system on the market. This presentation is meant for everyone, whether you’re already using the system and […]

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Trending: Investing In Social Listening Tools

It’s not easy to sift through and make sense of the vast amount of data posted each day by patients or their caregivers via social media. When it comes to unstructured data (e.g., abbreviations and acronyms), it’s even more difficult. However, it’s critical to evaluate the constant chatter to help detect or prevent possible issues, […]

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How Bad Data In FAERS Wreaked Havoc On Regeneron

  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 […]

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Good Chance Your Doctor Doesn’t Know Your Med’s Real Indication

  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 […]

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U.S. Military Keeping A Close Eye On Supplements

  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 […]

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Do You Have Any Questions For The Pharmacist?

  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, […]

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A Card That Fits In Your Genes

  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 […]

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Were Kim Kardashian’s Instagram Posts Worth It?

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, […]

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The Troubles With Adverse Event Reporting

  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 […]

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What Kim Kardashian Taught Me About Pharma

  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. 

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Detecting Adverse Events With Google? The FDA Is Interested.

Editorial Credit: Gil C / 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 […]

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When The System Fails To Keep Us Informed Of Adverse Events

  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 […]

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A Beefed-Up Version Of Yelp, But For Drugs

  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 […]

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Living In A Personalized World: Drug Dosing And Safety

  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. 

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Top 5 Life Sciences Blog Posts From March 2015

  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. 

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