Posts Tagged ‘FDA’

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 […]

Let’s tackle a tough one… It’s one thing to put IBM Maximo, an enterprise asset management solution, in the cloud. It’s something completely different to put IBM Maximo in an FDA-compliant cloud!  At Perficient, we don’t do the usual – we cater to the difficult and never been done before, crowd. Our cloud has been serving […]

I don’t often see FDA Warning Letters issued to Institutional Review Boards (IRBs), so, when I came across this one, I thought it was worth sharing with you. This particular IRB was found to be in violation of 21 CFR Part 56.115(a)(2), related to meeting minutes, and 21 CFR Part 56.115(a)(5), related to a complete […]

I enjoy reading FDA Warning Letters. They’re insightful and often entertaining. Sometimes, though, they’re kind of unbelievable. And, sometimes, they’re downright nauseating. Take, for example, this letter issued on February 19, 2016 to a principal investigator (PI) based in New York. FDA inspectors found him to be in violation of 21 CFR Part 312.62(b), related […]

  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 the Drug Trials Snapshots section of the […]

  In a time when the turnover rate for clinical monitoring positions in the U.S. hovers around 25%, it’s more important than ever to do more with less. With risk-based monitoring (RBM), contract research organizations (CROs) and sponsors can leverage data in existing IT systems to spot, rectify, and prevent issues related to the execution […]

  In my tenure here at Perficient, I’ve contributed to a number of guides for the life sciences industry. Each one has been informative and useful, but I can’t remember ever being as excited about any of them as I am about the newest one: Life Sciences is Going Digital. 

  On January 8, 2016, the FDA issued a warning letter that caught my attention. I can’t remember why I initially opened it; maybe because the company’s name had “pharm” in it, as opposed to “seafood” (which seems to be there a lot!). Once inside the letter, I found this in the opening paragraph: “This […]

  In “fun” news, the FDA wants to know if the use of animation in pharmaceutical advertising affects consumers’ general perception of drugs, as well as the side effects they can cause. According to a Notice posted on the Federal Register website, the FDA is looking to answer the following questions: 

  Dr. Robert Califf, a cardiologist who has spent most of his career at Duke University, was confirmed by the Senate on February 24, 2016, to be the next FDA commissioner, following President Barack Obama’s nomination in September 2015. 

  Patients who are being treated for diseases, such as cancer, often require multiple drugs to manage their conditions. For example, patients are often prescribed drugs that treat the actual disease, while others are meant to manage side effects from those drugs. Many of these patients can probably attest to inquiring about or doing their […]

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