Conference Spotlight Posts
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