Posts Tagged ‘FDA’

Background of Diabetic Market in the US According to a 2020 Center for Disease Control (“CDC”), the United States has approximately 34 million people with diabetes. Of these, the Juvenile Diabetes Research Foundation (JDRF) estimates that 7% are Type 1, meaning their body produces no insulin, and cannot survive without does of insulin. Of the […]

The Impact of Colon Cancer According to the National Institutes of Health (NIH), colon cancer is the third-leading type of cancer death in the United States. Cancer in the colon usually starts from polyps or other precancerous growths in the rectum or the colon (large intestine). As part of a colorectal cancer screening and surveillance […]

In a landmark effort to both guide and spur artificial intelligence (AI) and machine learning (ML) development in the medical field, the US Food and Drug Administration (FDA) has released an Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. Background The plan was created by the FDA’s Digital Health Center of […]

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. [Guide] 2018 Pharmaceutical And Medical […]

Our country is in the midst of an opioid epidemic. We are seeing staggering statistics of drug abuse, not to mention graphic images and videos of the effects drugs are having on families and their loved ones. While the FDA has taken a serious stance in the fight against drug abuse and has even come […]

When it comes to drug approvals, 2017 was a great year for the pharmaceutical industry. According to Reuters, the number of drugs approved in the United States was the highest number in 21 years. In fact, the 46 novel drugs that were approved was more than double what was approved in 2016. This figure doesn’t […]

It’s been awhile since I’ve written about FDA warning letters, so I thought I would take a look at the letters issued throughout the year and see if anything egregious (or at least interesting) came up. I was surprised to learn that the FDA issued letters to six separate clinical investigators, and I thought the […]

You know how you implemented that regulated IT system a few years ago, and it was all shiny and new, and then it went through a bunch of change controls and the validation documentation got kind of unwieldy, and now you’re kinda wishing you could start over with a clean slate, but without losing the […]

Now that November 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 October – they’re ranked in order of popularity, with number one being the most viewed piece. Aggregate Report Preparation In Safety […]

We are quickly coming up to the go-live of the MedDRA 20.1 dictionary. The new version; maintained by the MSSO was released in September 2017; per regulatory guidance will go live on the first Monday, two months after its release. This version, 20.1 will be live 06Nov2017. Our clients often have questions about upgrading their […]

The FDA has decided that it will update the ciphers for their Electronic Submissions Gateway (ESG), but what does this mean for you? Here is the message that was received: FDA Electronic Submissions Gateway (ESG) will update ciphers and SSL protocols in Production on Saturday, January 20, 2018 at 9:00 PM EST. Please make sure […]

Now that September 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 August – they’re ranked in order of popularity, with number one being the most viewed piece. What The FDA Requires Of […]