In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|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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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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