{"product_id":"guidebook-for-drug-regulatory-submissions-hardback-9780470371381","title":"Guidebook for Drug Regulatory Submissions (Hardback) 9780470371381","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eGuidebook for Drug Regulatory Submissions\u003c\/font\u003e\u003cbr\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003c\/p\u003e\n\u003cp\u003e\u003cfont size=\"4\"\u003eSandy Weinberg (Author)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9780470371381, Wiley\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 3 April 2009\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e400 pages\u003cbr\u003e24.5 x 16.3 x 2.7 cm, 0.717 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cem\u003e\u003cfont size=\"3\"\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)\u003c\/font\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003cp\u003e\u003cb\u003eDestined to become every regulatory director's essential desktop companion\u003c\/b\u003e  \u003c\/p\u003e\n\u003cp\u003eProfessionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. \u003ci\u003eGuidebook for Drug Regulatory Submissions\u003c\/i\u003e offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development.  \u003c\/p\u003e\n\u003cp\u003eDemystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines.  \u003c\/p\u003e\n\u003cp\u003eAs well, vital information is provided on the most common types of submissions, including: \u003c\/p\u003e\n\u003cul\u003e \u003cli\u003eMeeting Requests\u003c\/li\u003e \u003cli\u003eOrphan Drug Applications\u003c\/li\u003e \u003cli\u003eInvestigatory New Drug Applications (INDAs)\u003c\/li\u003e \u003cli\u003eNew Drug Applications (NDAs)\u003c\/li\u003e \u003cli\u003e505(b)2 NDAs\u003c\/li\u003e \u003cli\u003eAbbreviated New Drug Applications (ANDAs)\u003c\/li\u003e \u003cli\u003eAnnual Report\u003c\/li\u003e \u003c\/ul\u003e  \u003cp\u003eThis reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia.  \u003c\/p\u003e\n\u003cp\u003e\u003ci\u003eGuidebook for\u003c\/i\u003e \u003ci\u003eDrug Regulatory Submissions\u003c\/i\u003e is more than a useful guide—it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions.\u003c\/p\u003e\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\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\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Chemistry [\u003ca title=\"See our other books on Chemistry\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Chemistry%20%5BPN%5D%22\"\u003ePN\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Wiley","offers":[{"title":"Brand New","offer_id":52276181958936,"sku":"9780470371381","price":96.99,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/files\/9780470371381.jpg?v=1781364932","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/guidebook-for-drug-regulatory-submissions-hardback-9780470371381","provider":"Freshly Printed Books","version":"1.0","type":"link"}