The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: HITRUST

Wednesday Brain Dump: March 11, 2009

Regulatory Brain Dump…

Regulating Nanotech:  The FDA is collaborating with the Houston-based Alliance for NanoHealth (ANH) and its eight member institutions to expand knowledge of how nanoparticles behave and affect biologic systems.  Results will be placed in the public domain.

Regulating Natural Health Products: Health Canada launched the first phase of Online Solution, a secure online system for regulating natural health products in Canada.

Not Waiting for Regulation: Like Teva’s decision in February, Momenta Pharmaceuticals doesn’t think it needs to wait for a follow-on biologics pathway.  It’s proceeding with its application (presumably still a BLA) for a generic version of Lovenox, and unlike Teva, Momenta doesn’t think the FDA will require human trials for its product.

Commissioning Regulation:  A number of reports, including the In Vivo Blog and the WSJ Health Blog have been pointing to the nomination of Margaret Hamburg as FDA Commissioner, with Joshua Sharfstein as deputy.

Self-Regulation:

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