食品药品第1128节 行政安全与创新法案 （FDASA） 小型企业向国会报告

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1、Section1128oftheFoodandDrugAdministrationSafetyandInnovationAct(FDASIA)SmallBusinessReporttoCongress1TableofContentsOverview.............................................................................................................................3IdentifyingBarriersforSmallB

2、usiness..............................................................................4FDATakesanActiveRoleinProblem-SolvingforSmallBusiness.................................5I.FinancialAssistanceandIncentives.......................................................................

3、....5A.SmallBusinessUserFeeDiscounts......................................................................5B.GrantPrograms......................................................................................................7C.Waiversand/orExclusivity...........................

4、.........................................................8II.EnhancedAccessandInformation.........................................................................10A.DedicatedSmallBusinessAssistancePrograms.................................................10B.AccesstoOnlineResou

5、rces.................................................................................11C.EarlyCommunicationswithFDAExperts..........................................................12D.AccesstoOmbudsmen.............................................................................

6、...........13III.TargetedEducationandTraining...........................................................................13A.RegionalFace-to-FaceTraining..........................................................................13B.SeminarsandWebinars.............................

7、...........................................................13C.InternalTraining..................................................................................................14IV.InnovativeDevelopmentProgramsandApprovalPathways.................................15A.Breakthroug

8、hDesignation..........................................