Ralph S. Freedman, Maurie Markman
Abstract
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On December 14, 2006, the FDA published simultaneously in the Federal Register their proposed rules amending regulations for expanded access to investigational drugs and for charging patients for investigational drugs. These proposed rules, if approved, could have important implications for patients, providers, and for Pharma.
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On December 14, 2006, the FDA published simultaneously in the Federal Register their proposed rules amending regulations for expanded access to investigational drugs and for charging patients for investigational drugs. These proposed rules, if approved, could have important implications for patients, providers, and for Pharma.
Key concepts: Food and drug administration, Medicine, Investigational Drugs, Expanded access, Drug approval, Drug, Administration (probate law), Investigational device exemption