Sitemap - 2024 - The FDA Group's Insider Newsletter
[December 2024] Nitrosamine Control, Device Remanufacturing + Warning Letter Analysis
RA/QA News Roll: Mid December 2024 ❄️
Are You Ready for Your Next Data Integrity Audit?
Inside the FDA Warning Letter Over the Study of a Rejected Rare Disease Drug
Guidance Breakdown: FDA's BIMO Electronic Submission Requirements
Guidance Breakdown: FDA Sets New Expedited Withdrawal Procedures for Accelerated Approvals
Guidance Breakdown: PCCPs for AI-Enabled Device Software Functions
RA/QA News Roll: Late November 2024
One of the Most Concerning Warning Letters We've Seen in a While
The Smart Way to Adopt AI in Clinical Trials and Regulatory Affairs with Keith Parent
Guidance Breakdown: FAQs on Developing Potential Cellular and Gene Therapy Products
RA/QA News Roll: Mid November 2024
Demystifying AI in Life Sciences Supply Chain with Jennifer Chew
Recent Warning Letters Reveal Systemic Issues Across Device Firms
GAO: FDA Should Implement Strategies to Retain Its Inspection Workforce
2025 Audit Planning: 5 Things You Should Have Ready by Now
Overcoming Key Quality Challenges in Cell and Gene Therapy: A Q&A with Rafael Torres
SBOM Data Normalization in Medical Devices: 8 Takeaways From MITRE's New White Paper
RA/QA News Roll: Late October 2024
Guidance Breakdown: Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
Streamlining Promotional Review in the Life Sciences with Annalise Ludtke
A Simple Guide to Annual GMP Audit Planning
Navigating Supplier Audits in Japan with Derek Wessman
RA/QA News Roll: Mid October 2024
Guidance Breakdown: Electronic Systems, Records, and Signatures in Clinical Investigations — 29 Q&As
Inside FDA Pre-Approval Inspections with Former Investigator, Chris Smith
Guidance Breakdown: Our Top 10 Takeaways from the FDA's Guidance on Conducting Decentralized Trials
RA/QA News Roll: Late September 2024
Answering a Few FAQs About Navigating the 510(k) Process
The Anatomy of an Effective Supplier Audit Report
RA/QA News Roll: Mid September 2024
Guidance Breakdown: FDA Revises Its 2018 Guidance on Submitting Amendments to ANDAs
CDER Chief on Inspection Backlog: 2025 Will Be a 'Crucial Year'
A Quick Note on Finding Great RA/QA/Clinical Consultants These Days
Welcome to the Insider Newsletter
Guidance Breakdown: FDA Revises Its Final Guidance on Nitrosamine Impurities
RA/QA News Roll: Late August 2024
Small Lots, Big Risks: Rethinking Statistical Sampling in Biopharma
Guidance Breakdown: Predetermined Change Control Plans (PCCPs) for Medical Devices
10 Takeaways from the FDA’s QMSR Medical Device Companies Should Be Considering Now
4 Best Practices for Preventing CRLs in Biologics Manufacturing
Preparing for the QMSR: A Comprehensive Guide + Gap Analysis Worksheet
The FDA is Building an Active Postmarket Surveillance System for Medical Devices
Guidance Breakdown: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA
Mastering Quality Metrics: A Guide to Effective Scorecards with Kimberly Wallbank
RA/QA News Roll: Mid August 2024
[August 2024] Inside FDA's New BIMO Inspection Guidances and AI White Paper + Form 483 Breakdown
RA/QA News Roll: Late July 2024
The Consultants That Stayed: How Full-Time Experts Rebuilt a Company's Quality System
The FDA's Fiscal Year 2025 User Fees: A Quick Guide
A Quick Look at the Evolving Legal and Legislative Situation Surrounding the FDA's LDT Final Rule
Applying AI in the Life Sciences with MasterControl's Matt Lowe
RA/QA News Roll: Mid July 2024
FDA's CBER Revises its SOPP for Processing and Reviewing INDs: What Sponsors Need to Know
Navigating Challenges in Raw Material and Finished Product Storage with Eric Busenburg
What the Overturning of Chevron Could Mean for the FDA and Industry: A Roundup of Initial Analyses
Using Full-Time Consultants to Build a Quality Department: A Staff Augmentation Success Story
RA/QA News Roll: Late June 2024
Guidance Breakdown: Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
Modernizing Clinical Quality Management: A Q&A with Klaus Goodwin, EQSM, LSS BB
Building and Leading Effective Quality Assurance Teams with Aaron Snyder
Guidance Breakdown: FDA Issues 2 Draft Guidances Covering BIMO Inspections
The Pharma Startup Playbook: Advice from the Field with Taggart McGurrin
RA/QA News Roll: Mid June 2024
7 Key Takeaways From FDA's FY2023 Report on the State of Pharmaceutical Quality
The Passionate Workforce is Out Now — Grab it on Amazon
RA/QA News Roll: Late May 2024
Navigating FDA Regulations for SaMD AI and Machine Learning with VideaHealth's Adam Foresman
Guidance Breakdown: Remanufacturing of Medical Devices
Guidance Breakdown: REMS Logic Model — A Framework to Link Program Design With Assessment
FDA Officials Offer Tips on Responding to Warning Letters and 483s
RA/QA News Roll: Late April 2024
Crafting Quality Systems for Each Phase of Drug Development with Carlos Yuraszeck
Inside the FDA's Final Rule On LDTs
How to Write Effective SOPs: A Q&A with Klaus Goodwin, EQSM, LSS BB
Guidance Breakdown: Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies
RA/QA News Roll: Mid April 2024
Strategic Insights from Novartis's Front Lines: Leading Through Transition
Guidance Breakdown: Providing Regulatory Submissions in Electronic Format — IND Safety Reports
RA/QA News Roll: Late March 2024
Real Talk on Remote Leadership with Nick Klingensmith
The Passionate Workforce: How to Create and Maintain Maximum Employee Engagement
The QMSR Explained: The Busy RA/QA Leader's Guide to Compliance Planning
RA/QA News Roll: Mid March 2024
How to Use Interim Consultants and Contractors Effectively in 2024
5 Commonly-Overlooked Strategies for Supplier/Vendor Audits
The FDA Proposes Several Changes to NDA and ANDA Forms
FDA Guidance Breakdown: Key Information and Facilitating Understanding in Informed Consent
RA/QA News Roll: Late February 2024
The FDA is Ramping Up Manufacturing Inspections in India
10 Things You Should Be Doing to Verify Your Testing Labs' Data
10 Questions to Ask Your Testing Lab in Light of FDA's Alert on Fraudulent and Unreliable Data
Audit and FDA Inspection Readiness Best Practices with Divya Gowdar
RA/QA News Roll: Mid February 2024
Mastering the TMF: Ensuring GCP Compliance and Inspection Readiness with Donna Dorozinsky
RA/QA News Roll: Late January 2024
🚨 Breaking: The FDA Issues its QMSR Final Rule
FDA Guidance Breakdown: Revising ANDA Labeling Following Revision of the RLD Labeling
FDA Guidance Breakdown: Conducting Remote Regulatory Assessments Questions and Answers
RA/QA News Roll: Mid January 2024
A Unique Look Inside a 510(k) Development and Submission Project
Warning Letter Breakdown: Clinical Investigator Doesn't Adhere to Clinical Study Plan
A Former FDA Digital Health Staffer Graphs the FDA's MDUFA Performance Report Data
FDA Guidance Breakdown: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene