Sitemap - 2025 - The FDA Group's Insider Newsletter
Unannounced FDA Foreign Inspections Expand as Administration Pushes Domestic Manufacturing
RA/QA News Roll: Late April 2025
Tracking Major Changes at the FDA: April 25
FDA Warning Letter Breakdown: Quality Systems Fail at a Medical Device Manufacturer
The ICH Just Released Its Overhauled Stability Guideline for Consultation
15 Audit Questions That Could Save You From an FDA Warning Letter (Part 3)
Tracking Major Changes at the FDA: April 18
AI is Coming to Compliance—Here’s How It Will Help Your Team
RA/QA News Roll: Mid April 2025
15 Audit Questions That Could Save You From an FDA Warning Letter (Part 2)
Tracking Major Changes at the FDA: April 10
Tracking Major Changes at the FDA: April 9
Tracking Major Changes at the FDA: Insiders Say Inspection Operations Could Be Impacted by Layoffs
15 Audit Questions That Could Save You From an FDA Warning Letter (Part 1)
Tracking Major Changes at the FDA: April 7
RA/QA News Roll: Late March 2025
Inside 3 FDA Warning Letters: The Recurring CGMP Violations That Triggered Import Alerts
Tracking Major Changes at the FDA: Your 3-Minute Explainer
Is Your Feedback Helping or Hurting Performance? Insights from Quality Management Veteran Liz Troll
Leadership and the Touchstones of Effective Management with Joseph Carleone
Amazon Gets an FDA Warning Letter for Distributing of Unapproved Injectable Drug Products
RA/QA News Roll: Mid March 2025
What to Do Immediately Upon Receiving an FDA Form 483 or Warning Letter
5 Quick Takeaways From Martin Makary's Senate Confirmation Hearing
RA/QA News Roll: Late February 2025
A Smarter Approach to Supplier Quality Audits with Thermo Fisher's David Festa
6 Key Takeaways from the CDER's Drug Safety Priorities Report for Fiscal Year 2024
3-Minute Brief: Key Updates on the Lawsuits Challenging FDA’s LDT Final Rule After Oral Arguments
RA/QA News Roll: Mid February 2025
81 Days: Countdown to Stage 1 Compliance for the FDA's LDT Final Rule
Clinical Outsourcing & Insourcing: Selecting the Right Model or Mix with Mark Shapiro
FDA Uncovers Critical Manufacturing Violations at Chinese API Makers
Guidance Breakdown: Considerations for Complying With 21 CFR 211.110
Mastering FDA and EMA Regulatory Meetings with Ashley Preston
10 Overlooked Questions for Drug Manufacturing Inspection Readiness
How a Biotech Startup Filed 3 INDs in 1 Year Through Early Quality System Investment
Working with Chinese CROs: Benefits, Risks, and Best Practices with Harri Järveläinen
5 Takeaways from the FDA's 2025 IT Operations Plan
RA/QA News Roll: Late January 2025
[January 2025] FDA Inspection Readiness, EtO Policy Changes + Warning Letter Analysis
A Few Quick Tips for CAPA System Success in 2025
When the QA Manager Leaves: A 5-Month Staff Augmentation Success Story
RA/QA News Roll: Mid January 2025
The FDA Just Released a Ton of Guidance Documents
Guidance Breakdown: The FDA Updates its GUDID Final Guidance