Posts Tagged ‘FDA’

  I’m not going to get into whether prescribing or using drugs for off-label purposes makes sense – you can decide that for yourself. However, what I will tell you is that it’s a hot topic in the industry right now. Pharmaceutical companies continue to lobby the FDA to eliminate any prohibition of off-label promotion […]

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: Is a web-based training system required to be Part 11 compliant? 

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: Is a web-based quality management system that includes document control and CAPA modules required to be 21 CFR Part 11 compliant? 

  A recent article that I read alluded to the fact that regulatory bodies are struggling to keep their websites updated, which could lead to misinformation or a lack of information for consumers and companies interested in a country’s regulations and policies. The story specifically pointed to the English and Korean versions of South Korea’s […]

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: When Argus is hosted by Perficient, is it considered an open or closed system for the company that contracted Perficient to host? 

  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 […]

  I recently read an article, The Future of Cancer Treatment Is (Almost) Here, which discusses liquid biopsy, a method of using blood samples to detect cancer. While new forms of cancer detection and monitoring continue to be developed, we’ve already made significant strides in the treatment of certain diseases. 

  Inspired by our blog series from earlier this year, the head of our Computer System Validation team will be delivering a webinar on Thursday, April 23, 2015 aimed at “decoding” the 21 CFR Part 11 regulation. In the webinar, validation guru Sally Miranker will be reviewing the regulation point by point, offering up Perficient’s interpretation […]

  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. 

  Getting informed consent from patients is one of the most critical aspects of a clinical trial. The objective is simple: provide patients with information about the study plan (doctor visits, tests, etc.) and risks/benefits, make sure they understand the information, and get their (legally effective) consent to participate. The faster this is done, the […]