Sitemap - 2023 - The FDA Group's Insider Newsletter

FDA's Year-End Guidance Drop: A Detailed Breakdown

RA/QA News Roll: Late December 2023

[December 2023 Issue] FDA Updates Policies for Reviewing ANDAs, Details 510(k) Modernization with Trio of Draft Guidances + Warning Letter Breakdown

A Blueprint for Quality Culture with Vincent Cafiso

RA/QA News Roll: Mid December 2023

An FDA Inspection Survival Guide with Jonathan Wacks

Clinical Data Standards in Focus: SDTM Compliance with Sunil Gupta

New Study Finds FDA’s Inspection Pause May Have Compromised Drug Quality While Agency Says It's Ramping Back Up

FDA Guidance Breakdown: Verification Systems Under DSCSA for Certain Prescription Drugs

FDA's Proposed Rule to Regulate LDTs: 22 Questions Labs Should Start Asking Themselves Now

Aligning with Last Year's CSA Guidance: 10 Essential Questions for Device Firms

Warning Letter Breakdown: Poor Complaint Handling, Contamination Controls, and Minimizing Problems Tied to Defective Inhalers

RA/QA News Roll: Late November 2023

[November 2023 Issue] FDA Issues Guidance on Post-Warning Letter Meetings, Urges Firms to Treat Device Risk Management File as a ‘Living Document’ + Warning Letter Breakdown

Catch Up With Our Recent Issues Over the Holiday

FDA Guidance Breakdown: Translating Non-English GLP Study Reports

The Link Between Quality Culture and QA Communication Pathways with David Marks

A Few Thoughts on What FDA's OPQ Re-Org Could Mean for Industry

RA/QA News Roll: Mid November 2023

Mastering Medical Device Supplier Management with Paul Hakamaki

The Quality Leader's Q4 Checklist

Recent FDA Enforcement Trends with George Toscano

8 Questions to Ask When Planning Supplier Audits for 2024

Growing Your Career in RA/QA with Jessica Beaver

Inside FDA's Proposed Rule to Regulate Laboratory Developed Tests (LDTs)

RA/QA News Roll: Late October 2023

[October 2023 Issue] FDA Adopts ICH’s Revised Guidance on Mutagenic Impurities, Issues Final Guidance on Qualification of Medical Device Development Tools + Warning Letter Breakdown

How to Develop A Narrative Summary of Remedial Actions When Responding to Inspectional Observations

FDA Guidance Breakdown: Remote Interactive Evaluations (RIEs) of Drug Manufacturing and Bioresearch Monitoring Facilities

5 Things RA/QA Leaders Should Look for in a Consulting Firm's Contracts Before Engaging

Drug Delivery System Innovation and Leadership with Steve Knowles

FDA Guidance Breakdown: Quality Considerations for Topical Ophthalmic Drug Products (Updated for December 2023 Revision)

RA/QA News Roll: Mid October 2023

FDA Updates Its Policies for Reviewing ANDAs and Good ANDA Assessment Practices

Motivating Technical Teams in the Life Sciences: A Conversation with Rick Beatty

RA/QA News Roll: Late September 2023

[September 2023 Issue] Inside FDA’s New Drug Quality Report, Updates to the Pre-Sub Guidance + Warning Letter Breakdown

[Bonus Issue] Inside FDA's New Draft Guidance on Using "Alternative Tools" for Manufacturing Inspections

How to Overcome 5 Common Challenges in Computer System Validation (CSV)

RA/QA News Roll: Mid September 2023

RA/QA News Roll: Late August 2023

[August 2023 Issue] AI and Machine Learning: FDA Spells Out Specifics for Manufacturing, Another Perspective on PCCPs for AI/ML Devices + Warning Letter Breakdown

[Bonus Issue] Gap Analysis Remediation: A Guide to Resourcing and Implementation

RA/QA News Roll: Mid August 2023

RA/QA News Roll: Late July 2023

The Critical Role of 'Hyper-Targeting' in Rare Disease Drug Development with Dan Donovan

[July 2023 Issue] FDA's Draft Guidance on OTC Drug Submissions Content/Format, PCCPs for AI/ML Devices + Warning Letter Breakdown

RA/QA News Roll: Mid July 2023

RA/QA News Roll: Late June 2023

Applying FDA's Final ICH Q13 Continuous Manufacturing Guidance, Preparing for October's eSTAR Requirement + Warning Letter Breakdown

RA/QA News Roll: Mid-June 2023

Quality Management Review: Benchmarking Quantitatively!

RA/QA News Roll: May 2023

Navigating Risk Management in Medical Devices with Brian Dense

The 2023 Compliance Issue: Addressing the Top-Cited CFRs to Pharma and Device Firms + Warning Letter Breakdown

Introducing our Functional Service Program (FSP)

FDA Finalizes Guidance on REMS Format and Content, Preparing for Expanded Device Inspection Authority + Warning Letter Breakdown

RA/QA News Roll: March 2023

Inside FDA's Pre-Approval Inspections with Former FDA Investigator, Christopher Smith

Implementing ICH Q14’s Enhanced Approach to Analytical Method Development, FDA's Proposed Framework for Human Factor Info in Device Submissions + Warning Letter Breakdown

[Bonus Issue] Top 5-Year Trending FDA GMP Inspection Citations (FY2018 to FY2022)

Revised Compliance Guides for PAIs and GMP Drug Inspections, New Guidances On Device Post-Approval Studies, Postmarket Surveillance + Warning Letter Breakdown

The Insider Newsletter Mailbag

[Bonus Issue] Inspection-Related Policies in the Food and Drug Omnibus Reform Act

Alternative cGMP Compliance Methods for Combo Products, Device Production and Quality System Software Assurance + Warning Letter Breakdown