Former FDA oncology reviewer Paz Vellanki, MD, PhD, of Precision for Medicine, discusses how CDER's ARC program supports novel end points such as ctDNA for rare diseases and why sponsors should engage FDA early.
|Articles|October 15, 2002
- BioPharm International-10-01-2002
- Volume 15
- Issue 10
Survival Guide to FDA Inspections: Part 2, Conducting the Audit ? Ready or Not, Here They Come
Author(s)Massoud Lavian, Paul W. Allen
by Massoud Lavian and Paul W. Allen, Clarkston Consulting When an FDA inspection is imminent, it pays to have a plan. Start by getting your papers in order and your facility in a state of good repair. Train a team to manage interaction with inspectors. Coach your employees on how to answer questions. And don't forget to take notes.
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FDA Launches Major CGMP Reviewalmost 24 years ago
Process Validation: How Much to Do and When to Do Italmost 24 years ago
Biotech Will Recover!almost 24 years ago
GMPs and Pharmaceutical Labelingalmost 24 years ago
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