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[July 2026] ANDA Postapproval Requirements Consolidated, a Device Warning Letter About Broken Feedback Loops + Aseptic Filling Basics…
The FDA pulls the boilerplate out of ANDA approval letters and puts it in one place and cites a firm for a quality system that saw the hazard in one…
Jul 31
•
The FDA Group
17
1
41:45
[June 2026] CMC Flexibility for Cell and Gene Therapy, Finalized Human Factors Submission Guidance + a Data Integrity Warning Letter
The FDA loosens CMC requirements for cell and gene therapy products, publishes a yes/no flowchart that right-sizes human factors submissions, and we…
Jul 1
•
The FDA Group
7
1
50:08
[May 2026] FDA's NAMs Validation Framework, Finalized Patient Preference Information Guidance + Clinical Thermometer Warning Letter
CDER tells you how to put new approach methodologies in front of reviewers, FDA finalizes guidance on patient preference information across the product…
May 27
•
The FDA Group
7
1
1:14:09
[April 2026] FDA Form 483 Response Guidance, Weight Loss Device Framework + AI-Driven Device Warning Letter
The FDA finalizes how to respond when inspectors hand you a 483, publishes a premarket framework for weight loss devices, and sends a warning letter…
Apr 16
•
The FDA Group
15
1
56:40
[March 2026] MoCRA Records Access for Cosmetics, Medical Device Cybersecurity + OTC Sterility Warning Letter
FDA clarifies what investigators can demand from cosmetics under MoCRA, cybersecurity requirements align with QMSR, and a Texas OTC firm learns that…
Mar 9
•
The FDA Group
14
1
52:34
[February 2026] Bayesian Methods in Clinical Trials, Real-World Evidence for Devices + Warning Letter Analysis
A Bayesian methodology draft guidance for clinical trial design, a finalized RWE framework for medical devices, and a Georgia pharma facility with…
Feb 5
•
The FDA Group
6
32:41
[January 2026] IND Safety Reporting Guidance, eCopy Compliance in the eStar Era + Manufacturing Warning Letter
IND safety reporting guidance, prevent format holds in medical device submissions, and a warning letter that shows what happens when a cleaning products…
Feb 2
•
The FDA Group
2
35:54
[December 2025] Biosimilar CES Guidance, QMSR Pre-Market Submission Requirements + Warning Letter
FDA guidance that could cut months from biosimilar BLA timelines, what FDA expects in QMS documentation for 510(k)s and a warning letter where pooled…
Feb 2
•
The FDA Group
2
29:44
[November 2025] Alternative Facility Assessment Tools, Computer Software Assurance + Warning Letter Breakdown
FDA's guidance on alternative assessment tools for drug facilities, the new risk-based software validation framework, and a warning letter that reveals…
Feb 2
•
The FDA Group
2
57:15
[October 2025] FDA FY2024 Pharmaceutical Quality Report, QSR to QMSR Transition + Warning Letter Analysis
FDA's annual State of Pharmaceutical Quality report, a 120-day sprint for the QMSR, and a warning letter that reveals how pressure and habit erode…
Feb 2
•
The FDA Group
2
39:59
[September 2025] Quality Management Economics, Medical Device Small Business Fee Relief + Sterile Ophthalmic Warning Letter
We examine CDER's economic case for quality management investment, break down FDA's updated small business determination guidance for device user fees…
Feb 1
•
The FDA Group
1
52:24
[August 2025] FDA Remote Regulatory Assessments, Medical Device Cybersecurity + OTC Manufacturer Warning Letter
We examine FDA's finalized guidance making remote regulatory assessments a permanent oversight tool, break down the June 2025 cybersecurity guidance for…
Jan 31
•
The FDA Group
1
39:16
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