The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

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[February 2026] Bayesian Methods in Clinical Trials, Real-World Evidence for Devices + Warning Letter Analysis
Watch now (33 mins) | A Bayesian methodology draft guidance for clinical trial design, a finalized RWE framework for medical devices, and a Georgia…
 • The FDA Group
32:41
[January 2026] IND Safety Reporting Guidance, eCopy Compliance in the eStar Era + Manufacturing Warning Letter
Watch now (36 mins) | IND safety reporting guidance, prevent format holds in medical device submissions, and a warning letter that shows what happens…
 • The FDA Group
35:54
[December 2025] Biosimilar CES Guidance, QMSR Pre-Market Submission Requirements + Warning Letter
Watch now (30 mins) | FDA guidance that could cut months from biosimilar BLA timelines, what FDA expects in QMS documentation for 510(k)s and a warning…
 • The FDA Group
29:44
[November 2025] Alternative Facility Assessment Tools, Computer Software Assurance + Warning Letter Breakdown
Watch now (57 mins) | FDA's guidance on alternative assessment tools for drug facilities, the new risk-based software validation framework, and a…
 • The FDA Group
57:15
[October 2025] FDA FY2024 Pharmaceutical Quality Report, QSR to QMSR Transition + Warning Letter Analysis
Watch now (40 mins) | FDA's annual State of Pharmaceutical Quality report, a 120-day sprint for the QMSR, and a warning letter that reveals how pressure…
 • The FDA Group
39:59
[September 2025] Quality Management Economics, Medical Device Small Business Fee Relief + Sterile Ophthalmic Warning Letter
Watch now (52 mins) | We examine CDER's economic case for quality management investment, break down FDA's updated small business determination guidance…
 • The FDA Group
52:24
[August 2025] FDA Remote Regulatory Assessments, Medical Device Cybersecurity + OTC Manufacturer Warning Letter
Watch now (39 mins) | We examine FDA's finalized guidance making remote regulatory assessments a permanent oversight tool, break down the June 2025…
 • The FDA Group
39:16
[July 2025] ICH M13B Bioequivalence Waivers, FDA Q-Submission Program Update + OTC Manufacturing Warning Letter Analysis
Watch now (50 mins) | We examine ICH's draft M13B guideline enabling bioequivalence waivers for generic drug manufacturers and analyze FDA's updated…
 • The FDA Group
49:47
[June 2025] ICH Q1 Stability Guidelines Overhaul, FDA Retires QSIT for ISO 13485 Inspections + Medical Device Warning Letter Analysis
Watch now (61 mins) | We break down ICH's landmark draft revision consolidating stability guidelines into a single harmonized document, examine FDA's…
 • The FDA Group
1:01:27
[May 2025] FDA's New AI Guidance for Drugs and Devices, Offshore OTC Warning Letters + Import Alert Analysis
Watch now (43 mins) | We break down FDA's landmark draft guidance on AI credibility for drug and biologic submissions, examine new lifecycle management…
 • The FDA Group
43:18
[April 2025] Special Edition: FDA Downsizing, Leadership Changes + Pharma Warning Letter Analysis
Watch now (23 mins) | We examine what a smaller FDA means for regulated companies under new leadership, offer strategic guidance for navigating…
 • The FDA Group
22:59
[March 2025] In-Process Testing Guidance, 2024 Device Recall Analysis + Pharma Supply Chain Warning Letters
Watch now (52 mins) | We break down new FDA guidance on batch uniformity and in-process controls, examine the hidden patterns behind 2024's medical…
 • The FDA Group
51:59
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