The latest news and exclusive analysis across the FDA-regulated industries from former FDA professionals and industry experts. Save time gathering the critical industry intelligence you need to act on.
| Platform |  | Pricing | Freemium | Publishes | Daily |
|---|---|---|---|---|---|
| Issues | 570 | Founded | 5 years ago | Last Issue | 5 days ago |
| Active | |||||
Read this Newsletter
insider.thefdagroup.comLatest Issues
RA/QA News Roll: Late September 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
These RA/QA news rolls are available in full only to paid subscribers. Upgrade here. If you haven’t already taken our reader survey, it should only take 1 minu...
Dr. Robert Califf on What It Will Take for GLP-1s to Become a Public Health Success
Subscribe to our podcast, The Life Science Rundown, if you haven’t already.
Ask a cardiologist what success looks like, and you’ll most likely hear about the patients in front of them. Ask a public health official, and the answer will cove...
Dr. Robert Califf on What It Will Take for GLP-1s to Become a Public Health Success
We're honored to welcome Dr. Robert Califf, two-time Commissioner of Food and Drugs and founding director of the Duke Clinical Research Institute, to The Life Science Rundown.
Dr. Califf joins Nick Capman to talk about how GLP-1 therapies...
6 BLA Submission Tips From CBER, and How to Put Each One to Work
At RAPS Convergence, an FDA regulatory project manager walked through what makes a biologics license application easier to review. Here's what she said, plus some practical advice from our side.
At RAPS Convergence 2026 in Charlotte, Jenni...
A Few Lessons From a Clean Contract Lab Vendor Audit
We recently completed a requalification audit of a contract testing lab for a sponsor client. It turned up no observations, but what they were doing well still made a great list of lessons.
When we pull lessons from our audit work, they us...
Audience Metrics
Subscribers, engagement, traffic and sponsorship for The FDA Group's Insider Newsletter.
| Subscribers | Engagement | 77 | Monthly Web Visits | ||
|---|---|---|---|---|---|
| Accepts Sponsors | Estimated Cost per Ad | ||||
Chart Rankings
How this newsletter ranks in the official Substack charts.
| #97 |
Authors
The writers behind this newsletter.
The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates.
Frequently Asked Questions
How can I access the email archive for The FDA Group's Insider Newsletter?
You can find recent issues that have been published by The FDA Group's Insider Newsletter on Reletter by scrolling up to where it says Latest Issues. Tap on the link for any of the most recent emails or hit More Issues to see older ones.
How many subscribers does The FDA Group's Insider Newsletter have?
To see how many people subscribe to The FDA Group's Insider Newsletter, simply upgrade your Reletter account. We provide readership numbers and lots of other stats for this newsletter so you can decide if it's worth reaching out to.
How can I advertise in The FDA Group's Insider Newsletter?
Newsletter advertising can be extremely effective when it's done right. Before you pitch The FDA Group's Insider Newsletter as a potential sponsor or partner, make sure that you've done your research and checked its newsletter stats with Reletter.
Then, personalize one of our winning pitching templates and send it to the right person using the contact info provided.
How much does it cost to sponsor a publication like The FDA Group's Insider Newsletter?
Newsletter ad rates (or CPM) vary depending on many factors, including industry, number of subscribers, open rate, ad placement and more.
To find out how much an ad will cost, contact The FDA Group's Insider Newsletter using the contact information provided and ask for a copy of their media kit.
How can I find newsletters related to The FDA Group's Insider Newsletter?
Scroll up to where it says Related Newsletters to see other publications like The FDA Group's Insider Newsletter. You can also search our email newsletter directory to discover other newsletters that cover the topics you're interested in.
How do I contact The FDA Group's Insider Newsletter?
Reletter provides this newsletter's website URL above, where you will often find their contact information. We also provide links to associated social media accounts and pitching templates so you can reach out fast.