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Recent court decisions create a need for Orange Book review, make a hard choice about experimental drugs, and push pharmaceutical executives to think more about personal liability. Meanwhile, the FDA has begun the difficult task of analyzing nanotech risks.
No Right to an Experiment The D.C. Circuit rejected the Abigail Alliance’s campaign to alter the current FDA drug approval regime, thereby preserving the integrity of the clinical testing program that is critical to the FDA’s mission to promote the public health. by William Schultz and Carlos AnguloYou’re in the Target Zone Executives of pharmaceutical, biotechnology, and medical device companies must know and abide by myriad statutes and regulations. Recent events in the government’s drive to police off-label marketing of drugs suggest that executives should not feel so comfortable anymore. by Tracy A. MinerTime for Orange Book Audit Recent decisions from the Supreme Court and the Federal Circuit provide new declaratory judgment opportunities for generic drug companies. Innovator drug companies should consider heightened due diligence on their Orange Book-listed patents. by John D. Livingstone and Michael J. McCabe IIReporting on Nanotech As tiny-molecule nanotechnologies begin to infiltrate the American consumer marketplace, the Food and Drug Administration must grapple with how to regulate the safety and effectiveness of these products under its existing regulatory framework. by Marc J. Scheineson and Julie K. Tibbets

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