FDA Post-Warning Letter Meetings are Not Agency Consultations

A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Four

A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Three

A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part Two

A Deep Dive into Cell and Gene Therapy Regulatory Considerations: Part One

Is Raw FDA Data Skewing Your Analyses?

Should ICH Tackle Standard Development for CGT Products?

FDA on the Evolution of Biologics Inspections: Part III

How “Inevitable” Data Integrity Issues Cause Havoc: Part II

FDA on the Evolution of Biologics Inspections: Part II

FDA on the Evolution of Biologics Inspections: Part I

The Evolving Clinical Trial Ecosystem

Persistent Non-Compliance Leads to a Consent Decree

Japan’s PMDA Formalizing Post-Approval Change System Based on Recent Pilot

Senior Management Failures Lead to Patient Deaths, Prison Sentence

Post-Approval Change Management Protocol Pilot Aims to Reduce Approval Time

How “Inevitable” Data Integrity Issues Cause Havoc: Part I

Navigating Drug Approvals and Post-Approval Changes in the Asia-Pacific Region

Why am I Being Inspected Again So Soon After a Pre-Approval Inspection?

How To Get Drug Products Approved In Asia-Pacific Markets

Who Decides if my FDA Inspection is Classified OAI?

Getting Drugs Approved in Mexico, Argentina, Colombia, And Peru

How to Get New Drugs Approved in Brazil

Where is My EIR?

FDA on Compliance Issues in Pharma

CMC Challenges and Opportunities in Latin America

An FDA Perspective on Decentralized Clinical Trials: Part III

An FDA Perspective on Decentralized Clinical Trials: Part II

An FDA Perspective on Decentralized Clinical Trials: Part I

From Data Integrity to Data Culture

Five FDA Warning Letters Issued in Four Years for Fraudulent Cancer Drug

Extracting Specific Protocol Violations from Warning Letter Citations

FDA Issues First Notices of Noncompliance on ClinicalTrials.Gov

The Components of “Responsibilities of the Investigator” Observations

Perforated Tables in Cleanrooms Draw FDA Attention

Data Integrity and Your Clinical Investigator: What the Data Shows

Discolored HEPA Filters Recolored by Sterile Manufacturer

Inadequate Equipment Cleaning Leads to Cross Contamination, FDA Warnings

Change Management Failures Documented in FDA Warning Letter

Ensure Adequate Investigations at Your CMO With a QRM Mindset

Is Your Quality System Up to Par for Your Next FDA Inspection?

How One Pharma Firm Ensures Robust GMP CAPA Effectiveness at CMOs

UDI Compliance for Medical Devices: Part II

ICH Q9: Quality Risk Management Revision Focuses on Six Topic Areas

What is the Best Way to Prepare for an FDA inspection?

UDI Compliance for Medical Devices: Part I

FDA on Cross-Contamination, Sustainable Compliance, and Contract Ops

Quality Culture Assessments and Records Request Responses