Posts Tagged ‘FDA’

Top 5 Pharma & Medical Device Blog Posts From January 2018

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 […]

How Pharma Is Tackling Drug Abuse

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 […]

How Many Novel Drugs Were Approved In 2017?

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 […]

6 Investigators Received FDA Warning Letters In 2017

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 […]

A Compliant Do-Over For Regulated IT Systems

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 […]

Top 5 Pharma & Medical Device Blog Posts From October 2017

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 […]

MedDRA Upgrades: 4 Clarifications

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 […]

FDA Ciphers Update: What To Consider If You Have Argus Safety

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 […]

Top 5 Pharma & Medical Device Blog Posts From August 2017

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 […]

What The FDA Requires Of Drugs On The Market

This is the final post in a brief series of posts (five in total) designed to demystify the high cost of prescription drugs in the U.S. Today’s post focuses on the fourth and final stage the of the FDA drug approval process: post-marketing. Before we dive into the final stage, here’s a quick recap of […]

Post-Market Surveillance Of Drug Safety

This is the final post in our brief series on drug safety. If you missed any of the previous posts, here are the links: Why Monitoring Adverse Events And Drug Safety Signals Matters What Exactly Is An “Adverse Drug Reaction?” The Role Of Signal Detection In Drug Safety What Pharmacovigilance Means And Why It Matters […]

Four Steps To Assess And Mitigate Risk With Regulated IT Systems

Over the past several weeks, I’ve published a series of posts that talk about how to assess and mitigate risk with your regulated IT systems. The FDA recommends using a risk-based approach to accomplish this feat, and we agree, so we laid out a four-part approach for you: Assess a system for its regulated status […]

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