Posts Tagged ‘FDA’

If that title compelled you to open this post, then you know what 21 CFR Part 11 is, and you also know – as my 12-year-old step daughter would say – “the struggle is real.” 21 CFR Part 11 is perhaps the most famous (or infamous!) regulation published by the U.S. Food and Drug Administration […]

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. Oh My, Where Has The Time Gone? […]

Life sciences is one of the most heavily regulated industries in the United States. It takes 10 to 15 years and an average of $2.6 billion for a drug to reach pharmacy shelves. Stringent regulations formed by the FDA are major factors for the lengthy timelines and high costs, sometimes preventing people from receiving potentially […]

There are plenty of articles out there about how the pharmaceutical industry may be affected by Donald Trump’s presidency. The problem is that nobody exactly knows how things are going to pan out over the next few years. When it comes to health insurance, the price of drugs, and the quality of providers across the entire health […]

If you’re in the life sciences industry and are considering IBM Maximo for regulated uses, we’ve got good news: it’s capable of 21 CFR Part 11 compliance! And, if you’re not familiar with 21 CFR Part 11, Perficient has the ultimate guide to help you. Here are the three key areas of the regulation that govern […]

Whether or not we agree with President Trump’s executive orders and policies, on a daily basis, we are getting incredible insight into how he wants to change a number of industries. On Monday, President Trump spoke on reducing regulation and “doing a number” on specific financial rules. Yesterday, he met with executives from the life […]

One key area in clinical trials that could benefit from connected health digital solutions is capturing informed consent. Traditionally, patients have signed informed consent forms that are very text-heavy, yet they don’t really understand the rights, responsibilities, risks, and benefits of the study. Explaining the complex details of a trial can add a significant amount […]

This year’s presidential election invoked serious fear in the pharmaceutical industry, with the cost of drugs taking center stage for a good portion of some candidates’ campaigns. While what candidates say they’ll do could very well be different than what they’ll try to do, their words and records are enough to push pundits, investors, and […]

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 […]

In the European Union, the use of E2B(R3), along with IDMP, is in legislation, so not complying by the deadline could have legal repercussions. Non-compliance with the FDA and MHLW’s requirements could also bring unwanted scrutiny. More importantly, if an organization does not comply by the deadlines, they will not be able to send ICSRs […]

Yes, some validated systems can comply with E2B(R3). With respect to Oracle Argus Safety, the current version, 8.0.1, is able to comply with E2B(R3), Electronic Vaccine Adverse Event Reporting System (eVAERS), and Electronic Medical Device Reporting (eMDR) reporting requirements. If a company is simply looking to meet E2B(R3) requirements, we advise waiting to upgrade until […]

Now that August 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 July – they’re ranked in order of popularity, with number one being the most viewed piece. When Do Companies Have To […]