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FTC Enters the Debate over Follow-On Biologics |
July 16, 2009
Previously published on July 10, 2009
The Hatch-Waxman Act, enacted in 1984, allows generic drug manufacturers to get Food and Drug Administration (FDA) approval by relying on the safety and efficacy data of their competitors--innovators or brand drug manufacturers. The generic drug must be identical to the innovator's drug.
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The views expressed in this document are solely the views of the author and not Martindale-Hubbell. This document is intended for informational purposes only and is not legal advice or a substitute for consultation with a licensed legal professional in a particular case or circumstance. |
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