Posts Tagged ‘Food and Drug Administration’

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 […]

FDA Guidance On 21 CFR Part 11 And Mobile Tech In Clinical Trials

In June 2017, the United States Food and Drug Administration (FDA) issued a new draft guidance document for public comment: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers. You have until August 21, 2017, to share your thoughts and ideas about its content. The […]

What Happens During NDA Review In The FDA Drug Approval Process

This post is the fourth in a brief series about the FDA drug approval process. The series is designed to answer the question about why U.S. prescription drugs are so expensive by illuminating the FDA drug approval process, stage by stage. In my last post in this series, I focused on the clinical stage, and […]

Role Of Clinical Trials In The FDA Drug Approval Process

Last time, I published the second in a brief series of blog posts designed to provide insight into why prescription drugs in the U.S. cost as much as they do. The series is focused on explaining the FDA drug approval process in layman’s terms. My previous post focused on the first stage in the process, […]

CX Methodology And Site Relationships: Duke-FDA Case Study

If you haven’t read the previous posts in this series, be forewarned that this week’s post might be a little hard to follow, as it assumes you have all of the context from the series to-date. Still, I encourage you to dive in, and I’ll do my best to connect all of the dots for […]

Why You Need To Think Of Clinical Sites As Your Customers

Earlier this year, Duke University and the United States Food and Drug Administration (FDA) published a jointly conducted study focused on principal investigator (PI) retention. After surveying 201 PIs, they confirmed the industry’s suspicion that PI turnover is a serious issue: 54.2% of respondents reported that they completed a single clinical trial and then stopped. […]

Why U.S. Prescription Drugs Cost So Much

The pharmaceutical and biotechnology industry is an incredibly rewarding place to work. We get to help patients feel better, more effectively manage their conditions, cure their diseases, and even prevent them from getting sick all together. But the life sciences industry is not without its challenges. According to a recent Pharmaceutical Research and Manufacturers of […]

It’s Official: Dr. Scott Gottlieb To Lead FDA

One of the key issues and perspectives we outlined in our recent State of the Life Sciences Industry guide was President Trump’s intention to reform the Food and Drug Administration (FDA) through the elimination or significant modification of regulations. Part of his recipe for reforming the FDA included bringing in a new head of the […]