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5 GMP Audit Questions That Keep Catching Pharma Teams Off Guard
 • The FDA Group
FDA Uncovers Critical Manufacturing Violations at Chinese API Makers
 • The FDA Group
A Few Quick Tips for CAPA System Success in 2025
 • The FDA Group
Guidance Breakdown: Providing Regulatory Submissions in Electronic Format — IND Safety Reports
 • The FDA Group
Inside FDA’s 2024 Quality Report: What RA/QA Teams Need to Know
Foreign inspections surge, warning letters hit a five-year high, and API supply chains face mounting risk—what the FDA’s latest pharma quality report…
 • 
The FDA Group
The 4 Cs of MedTech Leadership with Sean Gallimore
Sean Gallimore is an executive consultant working with early-stage medtech startups. His previous work has included roles with Medtronic, Johnson …
 • 
The FDA Group
54:16
RA/QA News Roll: Mid August 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
 • 
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.
 • 
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…
 • 
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.
 • 
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.
 • 
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.
 • 
The FDA Group
RA/QA News Roll: Late July 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
 • 
The FDA Group
51:13
The Power (and Pitfalls) of Real-World Evidence with Dr. Manfred Stapff
A conversation with a seasoned clinical researcher and real-world evidence leader.
 • 
The FDA Group
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.
 • 
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…
 • 
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.
 • 
The FDA Group

FDA News

View all
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.
 • 
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…
 • 
The FDA Group
2
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.
 • 
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…
 • 
The FDA Group
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