{"product_id":"evaluation-of-the-adjustment-for-food-and-drug-administration-9781502918352","title":"Evaluation of the Adjustment for Changes in Review Activities Applied to the Prescription Drug User Fee Act (PDUFA) IV Workload Adjuster for FY 2009:","description":"The Prescription Drug User Fee Act (PDUFA) authorizes the Food and Drug Administration (FDA) to collect user fees for reviewing and processing applications for the approval of certain human drug and biological products. There are generally four types of applications reviewed: New Drug Applications\/Biologics License Applications (NDAs\/BLAs); Investigational New Drug Applications (INDs); Efficacy Supplements; and Manufacturing Supplements.1 More information on the Prescription Drug User Fee Act can be found at the following website: http: \/\/www.fda.gov\/ForIndustry\/UserFees\/PrescriptionDrugUserFee\/default.htm\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Food and Drug Administration\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 1502918358\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9781502918352\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Createspace Independent Publishing Platform\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 10\/31\/2014\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 38\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.25lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 11.02h x 8.50w x 0.08d","brand":"Food and Drug Administration","offers":[{"title":"Paperback","offer_id":48622944813311,"sku":"9781502918352","price":15.99,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.whiterainbookhouse.com\/products\/evaluation-of-the-adjustment-for-food-and-drug-administration-9781502918352","provider":"WR Book House","version":"1.0","type":"link"}