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|August 15, 2002
- BioPharm International-08-01-2002
- Volume 15
- Issue 8
Survival Guide to FDA Inspections: Part 1, To Prepare or Not to Prepare, There Is No Question
Author(s)Massoud Lavian, Paul W. Allen
by Massoud Lavian and Paul W. Allen, Clarkston Consulting Would your company survive a surprise inspection? An FDA inspection can be a nightmare that costs your company money, time, and reputation. Proactive managers understand the logic behind FDA regulations and prepare accordingly. This three-part survival guide to inspections (whether from FDA, a client, an investor, or a European agency) will sharpen your vision of your company?s regulatory compliance picture.
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Articles in this issue
about 24 years ago
Guest Editorial: Quality Agreements with Contract Laboratoriesabout 24 years ago
Inside Washington: User Fee Program Seeks to Spur Biotech Developmentabout 24 years ago
Analytical Advances: Mapping Proteins – the 2-D Electrophoresis Issueabout 24 years ago
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