The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

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RA/QA News Roll: Mid August 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
Innovative Product Approval Showcase: A Quick Mid-Year Roundup
From precision oncology breakthroughs to patient-driven diagnostics, here are some of the FDA’s most impactful approvals of 2025 so far.
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The FDA Group
The FDA Announces PreCheck: A Fast-Track for Building U.S. Drug Plants
A new two-phase “PreCheck” pathway could shave months off U.S. plant construction while turning early regulatory engagement into a competitive edge for…
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The FDA Group
2
The Economics of Quality—Why FDA Says It’s Time to Double-Down on a Mature QMS
A four-stage cost curve shows exactly where your QMS investment begins to compound returns. We break down the FDA's latest white paper.
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The FDA Group
Guidance Breakdown: Medical Device User Fee Small Business Qualification and Determination
The FDA updated its small business fee reduction framework with three distinct benefit tiers and streamlined processes.
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The FDA Group
FDA Warning Letter Breakdown: When Basic Testing Goes Missing at an OTC Drug Firm
Why a Colorado skin care manufacturer's quality failures led to a complete shutdown—and critical lessons for every manufacturer.
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The FDA Group

July 2025

RA/QA News Roll: Late July 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 Power (and Pitfalls) of Real-World Evidence with Dr. Manfred Stapff
A conversation with a seasoned clinical researcher and real-world evidence leader.
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The FDA Group
51:13
Streamlining Drug Safety: A Look at FDA's New Framework for Smarter Clinical Trial Data Collection
The CDER just published a new white paper on Selective Safety Data Collection. We dissect it.
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The FDA Group
Trump Gives Medical Device Sterilizers Two More Years to Comply with EtO Limits
President Donald Trump issued an executive order granting a two-year extension for medical device sterilization facilities to comply with the new limits…
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The FDA Group
FDA Warning Letter Breakdown: Inside a Potassium‑Chloride Collapse
Why another company's site is on the FDA’s radar—and what every QA/RA team should learn from it.
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The FDA Group
Guidance Breakdown: Inclusion of Pregnant and Breastfeeding Women in Clinical Trials (E21 Draft)
A new draft has sponsors expected to plan pregnancy and lactation data collection from the start—not as an afterthought.
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The FDA Group
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