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This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval. New chapters cover: the marketing of unapproved new drugs and FDA efforts to...

The history of Port Jefferson, a village on Long Island's North Shore, is rich with the lore of ships and the sea. Once called Drowned Meadow because of flooding at high tide, the town was renamed Port Jefferson in 1836. Those same harbor waters, which overran their banks, would become the natural resource that made Port Jefferson's first industry--shipbuilding--possible. By the mid-19th century, the village had become one of the principal shipbuilding centers on Long Island and a major port of entry. The names of many prominent shipbuilding families are preserved in the village's streets and...