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The FDA Group's Insider Newsletter

The FDA Group

The 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.

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Latest Issues

Recent posts by this newsletter. Browse the email archive.

[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, and analyze recent warning letters across multiple device firms.

2 months ago
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Paid

6 Key Takeaways from the CDER's Drug Safety Priorities Report for Fiscal Year 2024

The FDA's Center for Drug Evaluation and Research (CDER) just released its tenth annual "Drug Safety Priorities" report for fiscal year 2024 (ending September 30). While labeled as "priorities," it's essentially a comprehensive year-in-revi...

2 months ago
5
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3-Minute Brief: Key Updates on the Lawsuits Challenging FDA’s LDT Final Rule After Oral Arguments

Yesterday, Judge Sean D. Jordan of the District Court for the Eastern District of Texas heard oral argument in the consolidated suits against the FDA regarding the final rule to regulate laboratory-developed tests as medical devices.

2 months ago
5
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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 pharma operations.

2 months ago
7
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Paid

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