Form preview

Get the free Investigational New Drug Application Fda template

Get Form
NOTES to SponsorInvestigators: This template presents the sections that comprise the IND application. Guidance was derived from FDA IND regulations, FDA guidance documents and ICH Good Clinical Practice
We are not affiliated with any brand or entity on this form

Get, Create, Make and Sign investigational new drug application

Edit
Edit your investigational new drug application form online
Type text, complete fillable fields, insert images, highlight or blackout data for discretion, add comments, and more.
Add
Add your legally-binding signature
Draw or type your signature, upload a signature image, or capture it with your digital camera.
Share
Share your form instantly
Email, fax, or share your investigational new drug application form via URL. You can also download, print, or export forms to your preferred cloud storage service.

Editing investigational new drug application online

9.5
Ease of Setup
pdfFiller User Ratings on G2
9.0
Ease of Use
pdfFiller User Ratings on G2
To use the services of a skilled PDF editor, follow these steps:
1
Check your account. If you don't have a profile yet, click Start Free Trial and sign up for one.
2
Prepare a file. Use the Add New button to start a new project. Then, using your device, upload your file to the system by importing it from internal mail, the cloud, or adding its URL.
3
Edit investigational new drug application. Rearrange and rotate pages, insert new and alter existing texts, add new objects, and take advantage of other helpful tools. Click Done to apply changes and return to your Dashboard. Go to the Documents tab to access merging, splitting, locking, or unlocking functions.
4
Get your file. Select the name of your file in the docs list and choose your preferred exporting method. You can download it as a PDF, save it in another format, send it by email, or transfer it to the cloud.
With pdfFiller, it's always easy to work with documents. Check it out!

Uncompromising security for your PDF editing and eSignature needs

Your private information is safe with pdfFiller. We employ end-to-end encryption, secure cloud storage, and advanced access control to protect your documents and maintain regulatory compliance.
GDPR
AICPA SOC 2
PCI
HIPAA
CCPA
FDA

How to fill out investigational new drug application

Illustration

How to fill out investigational new drug application

01
To fill out an investigational new drug application, follow these steps:
02
Gather all necessary information and documents, such as the sponsor's name and contact information, proposed drug name, drug components and formulation, manufacturing details, and preclinical and clinical data.
03
Complete the FDA Form 1571, which serves as the cover sheet for the application. Fill in sections like the regulatory action and type, submission type, and whether it's an original or amendment application.
04
Prepare the Investigator's Brochure, which provides essential information about the drug, including its chemical and pharmacological properties, manufacturing details, safety, and clinical support.
05
Include detailed protocols for the proposed clinical trials, covering aspects such as study objectives, study design, patient inclusion and exclusion criteria, dosing and administration plans, and safety measures.
06
Submit nonclinical data, such as laboratory test results, animal study reports, and toxicology data to establish the drug's safety and potential risks.
07
Provide any relevant previous human experience data or clinical trial results if available.
08
Include information about the investigators and the clinical research sites that will be involved in conducting the trials.
09
Prepare a detailed list of the drug's components and their sources.
10
Prepare a Drug Master File if there are proprietary or confidential aspects of the drug's manufacturing process that are not disclosed in the application.
11
Submit the completed application to the appropriate FDA division along with the required fees and supporting documents.
12
Await the FDA's review and decision on the application, which may involve additional requests for information or clarification before approval.

Who needs investigational new drug application?

01
Various individuals and entities might need an investigational new drug application (IND), including:
02
- Pharmaceutical companies or sponsors who have developed a new drug and intend to conduct clinical trials to test its safety and efficacy.
03
- Investigators or researchers who want to conduct clinical trials involving an investigational drug.
04
- Medical professionals seeking to gain approval for the use of a new or off-label drug in a particular patient population.
05
- Academic institutions or research organizations involved in drug development and clinical trials.
06
- Regulatory authorities such as the FDA require IND applications for reviewing and approving the initiation of clinical trials.

What is Investigational New Drug Application Fda Form?

The Investigational New Drug Application Fda is a document which can be completed and signed for specific needs. Next, it is furnished to the relevant addressee to provide certain details of certain kinds. The completion and signing is available or using a suitable application like PDFfiller. These services help to fill out any PDF or Word file without printing them out. It also allows you to customize its appearance depending on your needs and put an official legal electronic signature. Once finished, the user sends the Investigational New Drug Application Fda to the respective recipient or several ones by mail and even fax. PDFfiller includes a feature and options that make your Word template printable. It provides a number of settings for printing out. It doesn't matter how you will deliver a form - physically or by email - it will always look professional and clear. In order not to create a new document from the beginning every time, make the original form as a template. Later, you will have a rewritable sample.

Instructions for the Investigational New Drug Application Fda form

When you are ready to start completing the Investigational New Drug Application Fda writable form, you need to make clear that all the required information is well prepared. This part is highly significant, as far as errors may result in unwanted consequences. It is usually unpleasant and time-consuming to resubmit an entire template, not to mention penalties resulted from blown deadlines. To handle the digits takes more attention. At a glimpse, there’s nothing complicated about this task. Nonetheless, it's easy to make an error. Experts suggest to store all data and get it separately in a file. When you have a writable sample so far, you can just export this information from the file. In any case, it's up to you how far can you go to provide actual and legit info. Check the information in your Investigational New Drug Application Fda form twice while filling all necessary fields. In case of any error, it can be promptly fixed via PDFfiller editor, so all deadlines are met.

How to fill Investigational New Drug Application Fda word template

In order to start submitting the form Investigational New Drug Application Fda, you need a blank. When you use PDFfiller for completion and submitting, you can obtain it in a few ways:

  • Get the Investigational New Drug Application Fda form in PDFfiller’s filebase.
  • Upload the available template with your device in Word or PDF format.
  • Finally, you can create a document all by yourself in PDFfiller’s creator tool adding all required objects in the editor.

Whatever option you prefer, you will have all features you need for your use. The difference is that the form from the library contains the required fillable fields, you will need to create them by yourself in the second and third options. But yet, it is dead simple thing and makes your sample really convenient to fill out. These fields can be easily placed on the pages, and also deleted. There are different types of those fields based on their functions, whether you’re entering text, date, or put checkmarks. There is also a signature field for cases when you need the document to be signed by others. You can put your own e-sign with the help of the signing tool. When you're good, all you've left to do is press the Done button and pass to the submission of the form.

Fill form : Try Risk Free
Users Most Likely To Recommend - Summer 2025
Grid Leader in Small-Business - Summer 2025
High Performer - Summer 2025
Regional Leader - Summer 2025
Easiest To Do Business With - Summer 2025
Best Meets Requirements- Summer 2025
Rate the form
4.9
Satisfied
36 Votes

For pdfFiller’s FAQs

Below is a list of the most common customer questions. If you can’t find an answer to your question, please don’t hesitate to reach out to us.

Upload, type, or draw a signature in Gmail with the help of pdfFiller’s add-on. pdfFiller enables you to eSign your investigational new drug application and other documents right in your inbox. Register your account in order to save signed documents and your personal signatures.
Install the pdfFiller app on your iOS device to fill out papers. Create an account or log in if you already have one. After registering, upload your investigational new drug application. You may now use pdfFiller's advanced features like adding fillable fields and eSigning documents from any device, anywhere.
You can make any changes to PDF files, such as investigational new drug application, with the help of the pdfFiller mobile app for Android. Edit, sign, and send documents right from your mobile device. Install the app and streamline your document management wherever you are.
Investigational New Drug (IND) application is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
Sponsors or applicants who intend to conduct clinical trials of investigational drugs or biological products in humans are required to file an investigational new drug application.
To fill out an investigational new drug application, sponsors must provide detailed information about the drug or biological product, the proposed clinical trial protocols, and any prior research data.
The purpose of an investigational new drug application is to ensure the safety and protection of human subjects participating in clinical trials, as well as to provide the FDA with sufficient information to evaluate the potential risks and benefits of the investigational product.
Information reported on an investigational new drug application includes preclinical data, clinical trial protocols, investigator information, manufacturing details, and any previous human experience with the investigational product.
Fill out your investigational new drug application online with pdfFiller!

pdfFiller is an end-to-end solution for managing, creating, and editing documents and forms in the cloud. Save time and hassle by preparing your tax forms online.

Get started now
Form preview
If you believe that this page should be taken down, please follow our DMCA take down process here .
This form may include fields for payment information. Data entered in these fields is not covered by PCI DSS compliance.