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FDA Uncovers Critical Manufacturing Violations at Chinese API Makers
 • The FDA Group
Guidance Breakdown: Providing Regulatory Submissions in Electronic Format — IND Safety Reports
 • The FDA Group
Guidance Breakdown: Considerations for Complying With 21 CFR 211.110
 • The FDA Group
A Few Quick Tips for CAPA System Success in 2025
 • The FDA Group
Tracking Major Changes at the FDA: April 25
The agency faces database setbacks, leadership changes, and legal challenges as staff cuts reshape regulation and enforcement.
 • 
The FDA Group
FDA Warning Letter Breakdown: Quality Systems Fail at a Medical Device Manufacturer
A long list of deficiencies offers a ton of lessons for device firms on what the FDA is finding and citing.
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The FDA Group
The ICH Just Released Its Overhauled Stability Guideline for Consultation
Here's a detailed breakdown plus a few questions for self-assessment.
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The FDA Group
15 Audit Questions That Could Save You From an FDA Warning Letter (Part 3)
In our final installment, we explore five overlooked—but frequently cited—compliance risks drawn from recent FDA enforcement actions.
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The FDA Group
Tracking Major Changes at the FDA: April 18
A leaked HHS budget reveals major FDA cuts, layoffs delay pediatric policy meeting, and biotech firms report review slowdowns.
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The FDA Group
AI is Coming to Compliance—Here’s How It Will Help Your Team
A primer on the shift from reactive audits to AI-powered compliance, and what it means for your team.
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The FDA Group
RA/QA News Roll: Mid April 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
 • 
The FDA Group
15 Audit Questions That Could Save You From an FDA Warning Letter (Part 2)
More real-world findings from FDA enforcement — and the audit questions every QA team should be asking. Part 2 of 3.
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The FDA Group
Tracking Major Changes at the FDA: April 10
Agency reorganization effects, tariffs for pharma, and biotech CEOs reporting FDA disruptions.
 • 
The FDA Group
Tracking Major Changes at the FDA: April 9
VAERS drama, executive firings, and a shrinking budget.
 • 
The FDA Group
Tracking Major Changes at the FDA: Insiders Say Inspection Operations Could Be Impacted by Layoffs
The FDA is planning for fewer food and drug inspections due to layoffs, officials say.
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The FDA Group
15 Audit Questions That Could Save You From an FDA Warning Letter (Part 1)
Real findings from recent enforcement actions — and the internal audit questions your QA team should be asking right now. Part 1 of 3.
 • 
The FDA Group
Tracking Major Changes at the FDA: April 7
Let's quickly catch up on the news.
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The FDA Group
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