HHS Form FDA 3398 2003 free printable template

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION COMMITMENT TO PROTECT NON-PUBLIC INFORMATION EMPLOYEE AGREEMENT Whereas access to non-public information from the files of the

How to fill out HHS Form FDA 3398

How to fill out HHS Form FDA 3398

1. Obtain the HHS Form FDA 3398 from the official FDA website or a designated office.
2. Enter the appropriate Applicant Information including your name, address, and contact details.
3. Complete the section for the Type of Application, providing specific details about your submission.
4. Fill in the Intended Use of the product, clearly describing its purpose.
5. Provide information about the Product Characteristics, including formulation and indications.
6. Include any additional documents or supporting information as required by the instructions.
7. Review the form for accuracy and completeness before signing.
8. Submit the form according to the provided submission guidelines, either electronically or by mail.

Who needs HHS Form FDA 3398?

1. Any entity seeking to submit a new drug application or biologics license application to the FDA.
2. Researchers or companies developing products that require FDA evaluation for safety and efficacy.
3. Organizations involved in the manufacturing or distribution of drugs or biologics intended for human use.

For pdfFiller’s FAQs

How do I edit HHS Form FDA 3398 in Chrome?

Install the pdfFiller Chrome Extension to modify, fill out, and eSign your HHS Form FDA 3398, which you can access right from a Google search page. Fillable documents without leaving Chrome on any internet-connected device.

How do I fill out HHS Form FDA 3398 using my mobile device?

You can easily create and fill out legal forms with the help of the pdfFiller mobile app. Complete and sign HHS Form FDA 3398 and other documents on your mobile device using the application. Visit pdfFiller’s webpage to learn more about the functionalities of the PDF editor.

How do I fill out HHS Form FDA 3398 on an Android device?

On Android, use the pdfFiller mobile app to finish your HHS Form FDA 3398. Adding, editing, deleting text, signing, annotating, and more are all available with the app. All you need is a smartphone and internet.

What is HHS Form FDA 3398?

HHS Form FDA 3398 is a form used to report adverse events related to drugs and biologics, such as unexpected side effects or safety issues.

Who is required to file HHS Form FDA 3398?

Health care providers, manufacturers, and sponsors of drugs and biologics are generally required to file HHS Form FDA 3398 when they encounter adverse events.

How to fill out HHS Form FDA 3398?

To fill out HHS Form FDA 3398, provide detailed information about the adverse event, patient demographics, drug information, and any relevant medical history. Follow the guidelines provided by the FDA for completing the form.

What is the purpose of HHS Form FDA 3398?

The purpose of HHS Form FDA 3398 is to ensure the safety of drugs and biologics by allowing the FDA to monitor and evaluate adverse events reported by health care professionals.

What information must be reported on HHS Form FDA 3398?

Information required on HHS Form FDA 3398 includes patient identification, details of the adverse event, relevant drug information, and any actions taken or further patient outcomes.