Tag Archive
The following is a list of all entries tagged with HCV:
Drug Regulators, FDA, Publish Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry; Availablity.
Filed in Diagnostic,manufacturing, May 24, 2010, 8:58 amThe guidance document provides recommendations to blood and plasma establishments, manufacturers, and testing laboratories that are implementing a licensed method for Human Immunodeficiency Virus Type 1 (HIV–1) Nucleic Acid Test (NAT) and Hepatitis C Virus (HCV) NAT, on testing individual samples or pooled samples from donors of human blood and blood components for HIV–1 ribonucleic acid (RNA) and HCV RNA.
EMEA re-post Draft Guidance on the Clinical Evaluation of Anti-virals intended for HepC
Filed in Uncategorized,clinical,regulatory, May 27, 2009, 2:44 pmThe EMEA has reposted draft guidance on the “Clinical Evaluation of Direct Acting Antivial Agents Intended for the Treatment of Chronic Hepatitis C”. the guidance was originaly posted in April 2008, but the EMEA has re-posted it
Entries