Author Description

This toolkit is the go-to resource for scientists, sponsors, investors, and other pharmaceutical industry pros. A lifestyle management toolkit for pharmaceutical and biotechnology products provides users with a thorough, concise, and highly organized handbook detailing U.S. pharmaceutical lifestyle management's practical and regulatory facets. A valuable aid to identifying regulatory opportunities and achieving the maximum effective patent life, the accessible Lifecycle Management Toolkit covers the gamut of drugs and biologics. This invaluable resource includes accessible knowledge and insights on pharmaceutical development phases, FDA approval pathways, coordination of patent protection with product labeling, bioequivalence requirements, new chemical entity data protection, labeling carve-outs, patent infringement litigation, patent term restoration reference product exclusivity, interchangeability exclusivity, orphan drug exclusivity, and pediatric exclusivity.