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When the QA Manager Leaves: A 5-Month Staff Augmentation Success Story
When a QA manager's sudden departure left critical systems in disarray, one experienced consultant stepped in to rebuild vendor management, implement…
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The FDA Group
RA/QA News Roll: Mid January 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
The FDA Just Released a Ton of Guidance Documents
The agency is kicking off 2025 with a trove of new guidance just weeks before the new administration takes over. Here's a handy reference to what just…
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The FDA Group
Guidance Breakdown: The FDA Updates its GUDID Final Guidance
The update makes minor revisions from the previous 2014 guidance, including the removal of now-unneeded FDA Preferred Terms or codes from the database…
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The FDA Group
RA/QA News Roll: Late December 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group

December 2024

[December 2024] Nitrosamine Control, Device Remanufacturing + Warning Letter Analysis
Watch now (17 mins) | This month we examine the FDA's evolving stance on pharmaceutical impurity controls and device remanufacturing requirements, while…
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The FDA Group
16:41
RA/QA News Roll: Mid December 2024 ❄️
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
Are You Ready for Your Next Data Integrity Audit?
Here's what our auditors look for and how to assess your own readiness heading into 2025.
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The FDA Group
Inside the FDA Warning Letter Over the Study of a Rejected Rare Disease Drug
Following the FDA’s rejection of Applied Therapeutics’ experimental drug for classic galactosemia, the company announced that it also received a warning…
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The FDA Group
Guidance Breakdown: FDA's BIMO Electronic Submission Requirements
The FDA just released its final guidance finalizing draft requirements from 2018 into binding requirements for electronic submission of clinical study…
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The FDA Group
Guidance Breakdown: FDA Sets New Expedited Withdrawal Procedures for Accelerated Approvals
The FDA just released new details on how it plans to expedite the withdrawal of certain accelerated approvals when drugs fail to show clinical benefit…
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The FDA Group
Guidance Breakdown: PCCPs for AI-Enabled Device Software Functions
The FDA's long-awaited final guidance maps out how AI/ML devices can evolve post-market. We break down the new PCCP guidance.
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The FDA Group
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