The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

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What to Do Immediately Upon Receiving an FDA Form 483 or Warning Letter
Here are the five most important best practices we recommend firms follow within the first 48 hours of receiving an enforcement action.
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The FDA Group
5 Quick Takeaways From Martin Makary's Senate Confirmation Hearing
Senators questioned him on various topics, including his stance on abortion pills, vaccine policies, and recent FDA staffing changes.
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The FDA Group
RA/QA News Roll: Late February 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group

February 2025

"Who Makes This Drug?" FDA Issues Warning Letter to a Contract Manufacturer Over Documentation Discrepancies and Non-Cooperation
The firm appears to have denied manufacturing a prescription drug product shipped to the US, despite documentation suggesting otherwise.
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The FDA Group
A Smarter Approach to Supplier Quality Audits with Thermo Fisher's David Festa
A conversation with David Festa, Director of Corporate Quality at Thermo Fisher Scientific, on rethinking pharmaceutical and medical device supplier…
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The FDA Group
41:42
[February 2025] BIMO Electronic Submissions, Device Shortage Reporting + Quality System Warning Letters
Watch now (31 mins) | We explore new FDA requirements for bioresearch monitoring electronic submissions, examine mandatory device shortage reporting…
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The FDA Group
30:40
6 Key Takeaways from the CDER's Drug Safety Priorities Report for Fiscal Year 2024
The FDA just released its annual drug safety report. Here's everything you need to know in a 3-minute read.
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The FDA Group
3-Minute Brief: Key Updates on the Lawsuits Challenging FDA’s LDT Final Rule After Oral Arguments
Long story short: the judge heard oral arguments and promised a summary judgment would be coming "soon."
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The FDA Group
Fake Data, Failed Tests, and More: Four FDA Warning Letters to Pharma Firms Reveal Fundamental CGMP Problems
Manufacturing facilities in India, Texas, and Florida demonstrate how fundamental quality issues continue to plague both domestic and international…
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The FDA Group
RA/QA News Roll: Mid February 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
81 Days: Countdown to Stage 1 Compliance for the FDA's LDT Final Rule
A question for labs with LDTs on the market: are you ready?
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The FDA Group
Clinical Outsourcing & Insourcing: Selecting the Right Model or Mix with Mark Shapiro
An insider's perspective on navigating CROs, FSPs, contractors, and FTEs in modern drug development.
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The FDA Group
32:57
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