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
Virus Inactivation in the 1990s ? and into the 21st Century: Part 3b, Plasma and Plasma Products (Treatments Other than Heat or Solvent/Detergent)
Author(s)Gail Sofer
by Gail Sofer, BioReliance The latest installment of our series on recently published methods for inactivating viruses reviews the literature on virus inactivation in plasma and plasma products by chemical treatments, gamma and UV irradiation, and low-pH treatment.
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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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