IND Forms and Instructions | FDA
WEBMar 31, 2022 · Instructions for forms. FDA's receipt of the IND. Forms: Form FDA 1571 (PDF - 221KB): Investigational New Drug Application (IND) Form FDA 1572 (PDF - 208KB): Statement of Investigator....
New and Updated FDA Forms | FDA - U.S. Food and Drug Administration
WEBThis page provides New and Updated FDA Forms related information. Updates to Forms FDA 356h and FDA 1571
How to Complete Form FDA 1571 and Form FDA 1572 | FDA
WEBNov 13, 2019 · FDA Form 1571 and FDA Form 1572 are used for submitting requests for an individual patient expanded access to investigational drugs (including biologics).
Initial IND Application | Clinical Center
WEBForm FDA 1571 Instructions. The purpose of the Form FDA 1571 is to: obtain agreement from the sponsor (or sponsor-investigator) to conduct research according to all appropriate FDA regulations; and; serve as a cover sheet for all submissions to the FDA on behalf of a particular IND. Form FDA 1571 should be completed for every submission sent to ...
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FORM FDA 1571
WEBList numbers of all Investigational New Drug Applications (21 CFR Part 312), New Drug Applications (21 CFR Part 314) , Drug Master Files (21 CFR Part 314.420) , and Biologics License Applications (21 CFR Part 601) referred to in this application.
21 CFR 312.305 -- Requirements for all expanded access uses.
WEB(i) A cover sheet (Form FDA 1571) meeting the requirements of § 312.23(a); ( ii ) The rationale for the intended use of the drug, including a list of available therapeutic options that would ordinarily be tried before resorting to the investigational drug or an explanation of why the use of the investigational drug is preferable to the use of ...
Form 1571 | Expanded Access Navigator - Reagan-Udall
WEBForm 1571. The initial IND submission and each subsequent submission to the IND should be accompanied by a Form FDA 1571. See Form FDA 1571 submission details here. Form 1571 and instructions for completing the form. Download PDF.
21 CFR Part 312 Subpart I -- Expanded Access to Investigational …
WEBThis subpart contains the requirements for the use of investigational new drugs and approved drugs where availability is limited by a risk evaluation and mitigation strategy (REMS) when the primary purpose is to diagnose, …
Clinical Trial Forms | FDA - U.S. Food and Drug Administration
WEBMar 7, 2022 · This page provides links to commonly used clinical trial forms relevant to clinical trials. FDA 1571 (PDF - 2MB) Investigational New Drug Application Instructions for completing Form FDA...
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
WEBMar 22, 2024 · (1) Cover sheet (Form FDA-1571). A cover sheet for the application containing the following: (i) The name, address, and telephone number of the sponsor, the date of the application, and the...
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