The FDA announced today (January 15, 2008) it will make final the guidance describing a regulatory framework for governing genetically engineered (GE) animals. The draft guidance was initially issued on September 18, 2008, and the agency took public comments until November 18, 2008.
Current revenue recognition accounting principles continue to place unnecessary challenges on small and medium-sized biotechnology companies who enter into collaborative arrangements, according to an independent study released in early October by BIO.
An AARP report released on Sept. 26 claimed that drug manufacturers substantially raised prices on the 144 specialty drugs most commonly used by people in Medicare Part D over the past five years. BIO issued a statement to refute the findings of the study, showing that the report ignores the impact of discounts, rebates, negotiated prices and patient assistance programs that help lower drug costs.
BIO this year became one of the sponsors of the International Genetically Engineered Machine (iGEM) competition. In this annual synthetic biology competition, teams of undergraduate students from around the world are provided a kit of biological parts from the Registry of Standard Biological Parts.
Policy Updates
Small Business Innovation Research Grants (SBIR)
Not sure what the SBIR issue is? Check out our Hopes and Cures Blog, and find out why stamping out SBIR will also stamp out hope for cures.
