Title: FORM FDA 1571 Author: PSC Publishing Services Subject: Investigational New Drug Application \(IND\) Created Date: 3/7/2018 10:38:42 AM From 1 June 2017 it is no longer possible to receive printed application forms and brochures from IND. Start the online application on www.ind.nl/en. Online application forms. Spouse or partner You can only download them from the website. The Immigration and Naturalisation Service (IND) processes personal data when it processes your application, notification, or request. For many residence permits you can apply using an online application form. Form FDA 1571 (PDF - 221KB): Investigational New Drug Application (IND) Form FDA 1572 (PDF - 208KB) : Statement of Investigator Form FDA 3674 (PDF - 411KB) : Certification of Compliance An Investigational New Drug Application (IND) is a request for Food and Drug Administration (FDA) authorization to administer an investigational drug to humans…

An online application is processed more quickly as you pay for the application when digitally sending your application. Legislation and regulations applicable to IND change several times a year and application forms and brochures need to be adjusted accordingly.

Send all the required documents together with your application.

Only submit the application once this form is fully completed and signed, therefore not in parts. This means that if needed the IND will request data from you yourself and other organisations or persons. The IND also uses and stores data and shares them with other organisations. Choose the button ‘Login Business Portal’ and login with eHerkenning. To use the online application form you need to have a DigiD with sms verification or the DigiD app. You only use this form if you have been recognised as sponsor by … The IND application must contain information in three broad areas: Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment as to whether the product is reasonably … It is also possible to submit and manage this application online. 1 Who can submit this application? Contents. Send the form to the Immigration and Naturalisation Service (IND).

When doing so, the IND strictly adheres to the