{"product_id":"new-drug-development-a-regulatory-overview-new-drug-development-mathieu-9781882615858","title":"New Drug Development: A Regulatory Overview (NEW DRUG DEVELOPMENT ( MATHIEU))","description":"\u003cdiv class=\"book-description\"\u003e\n\u003cp\u003e\u003cstrong\u003eNew Drug Development: A Regulatory Overview (NEW DRUG DEVELOPMENT ( MATHIEU))\u003c\/strong\u003e by Mathieu, Mark P.. hardcover edition. ISBN: 9781882615858.\u003c\/p\u003e\n\u003cp\u003eGo inside the drug development and FDA regulatory process with todays most authoritative and popular reference on the topic. In its all-new 2008 edition, New Drug Development: A Regulatory Overview addresses the most cutting-edge developments redefining how new drugs are developed and regulated today, including:\n\n* How the FDA Amendments Act of 2007 will affect everything from drug reviews to postmarketing requirements.\n\n* How the CDERs efforts to integrate a culture of drug safety has affected the centers structure and its new drug review and approval processes.\n\n* How CDERs much-anticipated January 2008 transition to the eCTD as the only valid esubmission format will affect the FDAs drug submission and review process.\n\n* How the FDA and industry are already integrating pharmacogenomics, computer simulation, and other emerging technologies to inform key decisions.\n\n* Which drug development strategies are fulfilling their promise and offering optimal returns for industry, given the explosion of accelerated development\/approval programs and pilot programs to speed the drug development and review process.\n\nFind out why New Drug Development is pharma\/biotechs go-to resource for regulatory, clinical, project management, training, and other drug development disciplines navigating the FDAs drug development approval processes.\u003c\/p\u003e\n\u003c\/div\u003e","brand":"Brand: Parexel Intl Corp","offers":[{"title":"Default Title","offer_id":44878388002869,"sku":"ByrdShop_1882615859","price":263.5,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0627\/8139\/0901\/files\/ByrdShop_1882615859_7eb4b816-20f4-46a0-aa0c-10d303d3ade5.jpg?v=1784489404","url":"https:\/\/atxbooks.com\/products\/new-drug-development-a-regulatory-overview-new-drug-development-mathieu-9781882615858","provider":"ATX Books","version":"1.0","type":"link"}