对于新药注册层面来讲,在新药临床试验申请(Investigational New Drug Application, INDA)和新药上市申请(New Drug Application, NDA/ Biologic License Application, BLA)阶段涉及的表格类型如下: IND阶段表格: ·Form FDA 1571 (PDF - 221KB): Investigational New Drug Application (INDA)新药临床试验IND申请,IND是药...
(Includeareacode) EmailAddress 7.NDA,ANDA,orBLAApplicationNumber8.SupplementNumber(Ifapplicable) PRODUCTDESCRIPTION 9.EstablishedName(e.g.,propername,USP/USANname) 10.ProprietaryName(TradeName)(Ifany) 11.Chemical/Biochemical/BloodProductName(Ifany) 12.DosageForm13.Strengths14.RouteofAdministration 15....
FDA新药许可申请审核及管理简介 在食品及药物管理局以下简称FDA管辖之内,药物审评及研究中心 Center for Drug Evaluation and Research,简称CDER专司新药之审核。 该中心之下分成二室:新药物审评第一
4. Sign and date below. 5. FORWARD THE COMPLETED FORM AND OTHER DOCUMENTS BEING PROVIDED TO THE SPONSOR. The sponsor will incorporate this information along with other technical data into an Investigational New Drug Application (IND). INVESTIGATORS ...
(FormFDA1S72)(RevisionJ1) Auddiionalcopieyureundiluplejpor OjiceofConamatricationsDivisionofDragDaarion CeaierRrDagEpalaerliondzaddResearc FFOOdCCPDFEScotinisPeariOm 10001NewHanmpshirehve,PlandaleBHig.0Fioor SiherSpringMD20993-0002 Phone:855-543.3784.or301-796-3400:Fa301-16353 ...
These records must be maintained for 2 years from the date FDA approves a marketing application for the drug under study or if FDA does not approve the drug or no application is filed for the drug, from the date the study is discontinued and FDA is informed (Id.). The investigator must...
Although the consistent use of non-FDA supported terms across all nonclinical studies within an application is recommended, it is understood that that this may not always be possible.如果申办者确定了FDA尚未接受特定标准术语的整个信息域,则申办者可以选择要使用的标准术语(如果存在)。FDA建议申办者将此...
药品注册申请号Drug Application Number 产品号Product Number 药物剂型或给药途径Dosage Form / Route of Administration 药品规格或剂量Strength 药品的市场状态Product Marketing Status---All---PrescriptionOver-the-counterDiscontinuedNone (Tentative Approval)For Further Manufacturing Use ...
内容提示: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug AdministrationMDUFA Foreign Small Business Certification Request For a Business Headquartered Outside the United StatesOMB Number 0910-0508Expiration Date: May 31, 2022PRA Statement: See next page.Application for FY 20 FY- October 1 ...
FDA-Dosage Form Dosage Form FDA Data Element Number. None.CDER Data Element Number. C-DRG-00201 Data Element Name. Dosage Form.Data Element OID: 2.16.840.1.113883.3.26.1.1.2Data Element NCI Concept ID: C42636 Version Number. 008 Description. This standard provides for ...