Get the up-to-date fda form 3926-2024 now

Show details

4.4 out of 5

480 votes

1 II. BACKGROUND. 2 A. B. Emergency Expanded Access for an Individual Patient. 4 OVERVIEW OF DRAFT FORM FDA 3926. This guidance introduces and describes draft Form FDA 3926 Individual Patient Expanded Access Investigational New Drug Application IND. When finalized draft Form FDA 3926 will be available for licensed physicians to use for expanded access requests for individual patient INDs. Individual Patient Expanded Access Applications Form FDA 3926 Guidance for Industry DRAFT GUIDANCE This gui ...

Here's how it works

01. Edit your form online

Type text, add images, blackout confidential details, add comments, highlights and more.

02. Sign it in a few clicks

Draw your signature, type it, upload its image, or use your mobile device as a signature pad.

03. Share your form with others

Send it via email, link, or fax. You can also download it, export it or print it out.

How to rapidly redact Fda form 3926 online

Ease of Setup

DocHub User Ratings on G2

Ease of Use

DocHub User Ratings on G2

Dochub is a perfect editor for updating your forms online. Adhere to this simple guide to edit Fda form 3926 in PDF format online for free:

Sign up and sign in. Register for a free account, set a strong password, and proceed with email verification to start managing your templates.
Add a document. Click on New Document and select the file importing option: upload Fda form 3926 from your device, the cloud, or a protected link.
Make changes to the template. Utilize the upper and left-side panel tools to change Fda form 3926. Insert and customize text, images, and fillable areas, whiteout unneeded details, highlight the important ones, and provide comments on your updates.
Get your documentation accomplished. Send the form to other people via email, create a link for quicker document sharing, export the template to the cloud, or save it on your device in the current version or with Audit Trail added.

Explore all the benefits of our editor right now!

See more fda form 3926 versions

We've got more versions of the fda form 3926 form. Select the right fda form 3926 version from the list and start editing it straight away!

Versions	Form popularity	Fillable & printable
2017	4.8 Satisfied (150 Votes)
2015	4.4 Satisfied (480 Votes)

be ready to get more

Complete this form in 5 minutes or less

Get form

Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

Which Form FDA is used for new drug application field report *?

You can use Form FDA 3331a to submit FARs for CDER or CBER regulated drug products that are approved under an NDA or ANDA.

What is a FDA Form 1571?

What is a FDA Form 1571? The FDA Form 1571 or '1571' is the IND application cover page and it must accompany the initial IND submission and any amendments, IND safety reports, annual reports or general correspondence the sponsor submits to the FDA about the IND.

What form is submitted for an investigational new drug application IND )?

Form 1572 (PDF - 718KB) (Investigator's statement), and. Form 3674 (PDF - 3MB) (certification requirement & mandatory registration and reporting of results for applicable clinical trials through ClinicalTrials.gov.)

Which Form FDA is used for new drug application field report?

You can use Form FDA 3331a to submit FARs for CDER or CBER regulated drug products that are approved under an NDA or ANDA.

What is needed for an IND submission?

Filing an IND requires completion of 3 sets of forms: 1 detailing the study (FDA Form 1571), 1 providing information about the investigator and study site (FDA Form 1572), and 1 certifying that the study is registered in the national database of clinical trials (FDA Form 3674).

Related forms

be ready to get more

Complete this form in 5 minutes or less

Get form

What is EIND?

Emergency Investigational New Drug (EIND) Applications for Antiviral Products.

How do I submit an IND application?

What is Form FDA 356h?

Food and Drug Administration. APPLICATION TO MARKET A NEW OR ABBREVIATED NEW. DRUG OR BIOLOGIC FOR HUMAN USE.

What are FDA forms?

FDA forms are the way of communication between FDA and the drug manufacturing firms. These forms are issued at different stages of FDA inspection.

What is FDA 356h?

Food and Drug Administration. APPLICATION TO MARKET A NEW OR ABBREVIATED NEW. DRUG OR BIOLOGIC FOR HUMAN USE.

Get the up-to-date fda form 3926-2024 now

Here's how it works