CBER Director Wilson Bryan On How To Cut CGT Product Approval Times In Half

Gene and T-cell therapies hold promise for treating rare and debilitating diseases that in the past had no

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

This is the third part of a three-part story on CMC filing challenges and opportunities in Latin

FDA Takes Quality Systems Approach to CGT Inspections

In June, CBER Division of Manufacturing and Product Quality Facilities Reviewer and Investigator Ekaterina

FDA Warning Letters Week Of 11/8/2020: Unapproved Cord Blood Product & No Process Validation

Of the two drug-related FDA Warning Letters issued last week, one, issued to a homeopathic drug

FDA Warning Letters Week Of 11/1/2020: Unapproved HTC/P, Hold Times, & FD&C Violations

FDA posted two drug-related Warning Letters and one untitled letter to a firm marketing a cell-based

FDA Warning Letters Week Of 10/25/2020: Cleaning Validation & Foreign Particles

Last week, FDA posted two drug-related Warning Letters. One was issued to a drug packager and listed two

How to Identify Data Integrity (and Other) Trends

Why should firms review regulatory noncompliance data?  What useful information can be gained via

An Update On 503B Outsourcing Facilities

In response to the 2012 fungal meningitis outbreak that occurred at the New England Compounding Center

Data Integrity 101: Why is it Important?

In recent years, significant data integrity lapses have occurred at global pharmaceutical, biotechnology,

Webinar – Comparing and Analyzing Russian, UK, and US Top Ten Pharma Inspection Findings FY 2019

Webinar – Deploying Risk-Based Thinking within Management Systems

Webinar – Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends

Report – FY2018 Drug GMP Warning Letters

Report – State of Pharmaceutical Quality

Report – Peter Baker IP

Assessment – Investigator Snapshot

Assessment – Peer Benchmark Report

Assessment – CFR Trend Report