The FDA Group's Insider Newsletter
The FDA GroupThe latest news and exclusive analysis across the FDA-regulated industries from former FDA professionals and industry experts. New issues every month. Save time gathering the critical industry intelligence you need to act on.
| Platform |  | Pricing | Freemium | Publishes | Daily |
|---|---|---|---|---|---|
| Issues | 174 | Subscribers | Read | insider.thefdagroup.com |
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Latest Issues
Recent posts by this newsletter. Browse the email archive.
Inside FDA Pre-Approval Inspections with Former Investigator, Chris Smith
A few years back, we sat down with former FDA Investigator and current consultant Chris Smith to discuss how FDA plans and conducts its PAIs — and how industry teams can effectively prepare for them.
Guidance Breakdown: Our Top 10 Takeaways from the FDA's Guidance on Conducting Decentralized Trials
The FDA’s final guidance on DCTs adds clarity on HCP task log, inspection requirements, and data variability. We break it down.
RA/QA News Roll: Late September 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
Answering a Few FAQs About Navigating the 510(k) Process
The FDA 510(k) submission process is complex and can be challenging for companies, especially those unfamiliar with the regulatory requirements. Over the many years we've spent helping device firms gain market clearance through this pathway...
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The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates.
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