{"product_id":"guidebook-for-drug-regulatory-submissions-9780470371381","title":"Guidebook for Drug Regulatory Submissions","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eThe high-stakes process of submitting drug documents and applications for regulatory review can be intimidating, particularly for the inexperienced regulatory professional charged with preparing a major regulatory submission.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e“The Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development.” (\u003ci\u003ePharmaceutical Outsourcing\u003c\/i\u003e, April 2009)\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003ePreface ix\u003c\/p\u003e \u003cp\u003eChapter 1 Ten Rules for Drug Regulatory Submissions 1\u003c\/p\u003e \u003cp\u003eChapter 2 FDA Meeting Requests 44\u003c\/p\u003e \u003cp\u003eChapter 3 Orphan-Drug Applications 64\u003c\/p\u003e \u003cp\u003eChapter 4 Investigational New Drug Applications (INDs) 82\u003c\/p\u003e \u003cp\u003eChapter 5 New Drug Applications (NDAs) 120\u003c\/p\u003e \u003cp\u003eChapter 6 505(b)2 New Drug Applications (NDAs) 183\u003c\/p\u003e \u003cp\u003eChapter 7 Abbreviated New Drug Applications (ANDAs) 255\u003c\/p\u003e \u003cp\u003eChapter 8 Annual Reports 288\u003c\/p\u003e \u003cp\u003eChapter 9 International Regulatory Submissions 315\u003cbr\u003e\u003ci\u003eCarl A. Rockburne\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 10 Future Issues in Regulatory Submissions 355\u003c\/p\u003e \u003cp\u003eIndex 367\u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49402316980567,"sku":"9780470371381","price":99.86,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9780470371381.jpg?v=1730480048","url":"https:\/\/bookcurl.com\/products\/guidebook-for-drug-regulatory-submissions-9780470371381","provider":"Book Curl","version":"1.0","type":"link"}