Posts Tagged ‘FDA’

  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. 

  As a user of 23andMe since 2008, I’ve been closely following the company, especially since the FDA told them in 2013 to stop marketing their personal genetics testing service. At last, the FDA has given 23andMe the green light. Not surprisingly, the positive news pushed the cost of the genetics test from $99 to […]

  On September 24, 2015, the FDA issued a Warning Letter to a manufacturer and distributor of medical devices for several violations. While the issues at hand may not seem severe, they do put the public at risk and reduce the confidence that the FDA has in the organization. Plus, they are inviting unwanted scrutiny […]

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 […]

  We often hear the term “rare disease,” yet many of us still wonder exactly how “rare” is defined. In a recent blog post, Dr. Jonathan Goldsmith, the FDA’s Associate Director for Rare Diseases, shared some staggering statistics, as well as insights into how the FDA is making it easier to develop drugs for unusual […]

  This is fascinating on many levels. On July 31, 2015, the FDA has approved – for the first time in history – a drug that is developed on a 3-D printer. Not a medical device or a toy figurine; a drug. Aprecia Pharmaceuticals is the maker of SPRITAM, which is designed to treat seizures […]

  In May, I wrote about how pharmaceutical companies were attempting to stop the FDA from banning the promotion of drugs for off-label uses. According to an Amarin press release issued on August 7, 2015, a United States District Court sided with the pharmaceutical company, saying that they “…may promote to healthcare professionals certain uses […]

  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. 

  Naming drugs and medical devices is an art form that requires creativity, knowledge of linguistics, and an understanding of how to navigate the regulatory landscape. It’s easy to think of names, but coming up with ones that are meaningful and memorable, yet different enough than anything currently on the market, is another story. The International […]

  Over the past few months, the life sciences practice has produced several free resources related to the 21 CFR Part 11 regulation that governs electronic records and electronic signatures. To make it easy for our industry colleagues to find those resources, we decided to create a single blog post that links to all of […]

  According to a recent research letter in the Journal of the American Medical Association (JAMA), an analysis of serious adverse event (SAE) reports from January 1, 2004 and June 30, 2014 (with certain exclusions) concluded that drug companies were more likely to delay the reporting of such instances within the required 15 calendar days, if […]