{"product_id":"regulatory-ip-essentials-of-lifecyle-management","title":"Regulatory IP Essentials of Lifecyle Management","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.\u003cbr\u003eASIN: 1947779230\u003cbr\u003eVSKU: BVV.1947779230.G\u003cbr\u003eCondition: Good\u003cbr\u003eAuthor\/Artist:Gregory J. Glover, MD JD|Rylann Watts\u003cbr\u003eBinding: Perfect\u003cbr\u003e\u003cb\u003eNote:\u003c\/b\u003e Any images shown are stock photographs and product may differ from what is shown.  \u003cbr\u003e\u003cb\u003eCondition Notes\u003c\/b\u003e: The item shows wear from consistent use, but it remains in good condition and works perfectly. All pages and cover are intact  including the dust cover, if applicable . Spine may show signs of wear. Pages may include limited notes and highlighting. May NOT include discs, access code or other supplemental materials.  \u003cbr\u003e","brand":"Blue Vase Books","offers":[{"title":"Default Title","offer_id":43298200092733,"sku":"BVV.1947779230.G","price":11.06,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0589\/4225\/9261\/files\/1947779230-0.jpg?v=1782507816","url":"https:\/\/www.bluevasebooks.com\/products\/regulatory-ip-essentials-of-lifecyle-management","provider":"Blue Vase Books","version":"1.0","type":"link"}