The BBC reported today that the Food and Drug Administration has issued a license allowing for the use of embryonic stem cells to Geron Corporation, a biopharmaceuticals company that develops treatment for cancer and chronic degenerative diseases. Trials in an Atlanta hospital will determine whether the treatment, through which stem cells that have been “coaxed to become nerve cells…are injected into the spinal cord” of patients who have suffered a spinal cord injury in the last two weeks.
The law firm of Faegre & Benson published more news on the FDA today, in a memo entitled “FDA Announces New Drug Safety Reports: Declare Your Risk.” Author Christin E. Garcia articulates how the FDA has issued a final rule “governing safety analysis and reporting requirements for drugs under clinical investigation, even after they are on the market.” Attempting to comply with international standards, the agency is apparently seeking limit and make more useful the adverse reaction reports it receives. Garcia goes on to examine how subtle changes in language will affect the reality of reporting to the FDA when the new rule takes effect in March 2011.
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