Entries from HEALTH LAW SECTION BLOG tagged with 'IRB'

1/23/09 World's first HESC-based therapy in man by Geron

Big News Release from Geron's Website:1/23/09 Geron Corporation (1) announced that: the FDA has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury. The clearance enables...

Update your CDER bearings

For more information on clinical investigators, protection of human subjects, and regulatory and compliance programs, a recent CDER news item sugggests CDER's "Information for Clinical Investigators" webpage. This webpage provides guidance for conducting clinical trials with investigational drugs and information...

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