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Food and Drug Law

2009

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Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget Jan 2009

Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget

Michigan Telecommunications & Technology Law Review

Among the many amendments found in the Food and Drug Administration Amendment Act of 2007 (FDAAA) is a provision at the end of the act, Section 505(u), which grants chiral switches five years of market exclusivity under certain circumstances. Prior to Congressional enactment of the FDAAA, the Food and Drug Administration (FDA) refused to award new chemical entity (NCE) status to enantiomers of previously approved racemic mixtures. The FDA defines a new chemical entity ("NCE") as a drug that contains no active moiety that has been approved by the FDA in any other application submitted under Section 505(b ...