HHS Form FDA 3674 2019 free printable template

Form Approved: OMB No. 09100616. Expiration Date: 3/31/2021. See PRA Statement below. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug AdministrationCertification of ComplianceUnder 42 U.S.C.

How to fill out HHS Form FDA 3674

How to fill out HHS Form FDA 3674

1. Start by obtaining HHS Form FDA 3674 from the official FDA website or through your institution.
2. Fill in the applicant's name, address, and contact information in the designated sections.
3. Indicate the research study title and provide the name of the sponsor or institution.
4. In the 'Study Information' section, complete the details about the type of research and the location of the study.
5. Include any applicable regulatory information, such as IND or IDE numbers, if relevant.
6. Sign and date the form in the appropriate fields to validate the information provided.
7. Review all entries for accuracy and completeness before submission.
8. Submit the completed form as per the guidance provided by the FDA or your institution.

Who needs HHS Form FDA 3674?

1. Researchers conducting clinical trials involving human subjects.
2. Institutional Review Boards (IRBs) involved in the oversight of clinical studies.
3. Pharmaceutical sponsors applying for FDA approval of new drugs or devices.

People Also Ask about

What is Section 505 of the FDCA?

No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) of this section is effective with respect to such drug.

What is Section 505 O )( 3 )( E )( II of the FDCA?

Section 505(o)(3) of the Act authorizes FDA to require postmarketing studies or clinical trials at the time of approval or after approval if FDA becomes aware of new safety information.

What are the examples of changes to approved drug products for which 505 B )( 2 application should be submitted?

Ideal 505(b)(2) candidates include: Drugs with changes in dosage form, strength, formulation, dosing regimen or route of administration. New combination products. Prodrugs of an existing drug. In some cases, drugs with new active ingredients.

What are the FDA record retention requirements for drugs?

The retention period shall be no less than five years after the records of manufacture have been completed or six months after the latest expiration date for the individual product, whichever represents a later date. (2) Records of recall.

What is Section 402 J of the Public Health Service Act?

delegates the authority contained in section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)). Serious adverse event means an adverse event that results in any of the following outcomes: Death, a life-threatening adverse event as defined in 21 CFR 312.32, inpatient hospitalization or.

What is the FDA Form 3454?

Form FDA 3454, or the Financial Certification or Disclosure Statement, is used to submit information regarding clinical investigators who participated in the clinical studies. If no clinical studies were performed, simply state: “no clinical studies were performed to test this device.”

What is the FDA 3455 guidance?

applicants may submit a single FORM FDA 3455, with attachments clearly identifying all clinical investigators with information to disclose and, for each investigator, identifying the study, the specific details of their financial interests and arrangements and the steps taken to minimize the potential for bias.

What is the FDA Form 3455?

applicants may submit a single FORM FDA 3455, with attachments clearly identifying all clinical investigators with information to disclose and, for each investigator, identifying the study, the specific details of their financial interests and arrangements and the steps taken to minimize the potential for bias.

What is the purpose of FDA form 3454?

Form FDA 3454, or the Financial Certification or Disclosure Statement, is used to submit information regarding clinical investigators who participated in the clinical studies. If no clinical studies were performed, simply state: “no clinical studies were performed to test this device.”

What is 3674?

Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions.

What are the 5 steps for FDA approval?

Content current as of: Step 1: Discovery and Development. Step 2: Preclinical Research. Step 3: Clinical Research. Step 4: FDA Drug Review. Step 5: FDA Post-Market Drug Safety Monitoring.

What is a FDA Form 3674?

Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff.

What are the steps for FDA approval?

FDA Drug-Approval Process. A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, clinical research, FDA review and FDA post-market safety monitoring.

What are the phases of FDA drug approval?

Phase 1 studies (typically involve 20 to 80 people). Phase 2 studies (typically involve a few dozen to about 300 people). Phase 3 studies (typically involve several hundred to about 3,000 people). The pre-NDA period, just before a new drug application (NDA) is submitted.

How long does it take to get approved for FDA?

The FDA approval process can take between one week and eight months, depending on whether you self-register, submit a 510(k) application or submit a Premarket Approval (PMA) application. Bringing a medical device to market is not a fast process.

For pdfFiller’s FAQs

How can I manage my HHS Form FDA 3674 directly from Gmail?

You can use pdfFiller’s add-on for Gmail in order to modify, fill out, and eSign your HHS Form FDA 3674 along with other documents right in your inbox. Find pdfFiller for Gmail in Google Workspace Marketplace. Use time you spend on handling your documents and eSignatures for more important things.

How can I get HHS Form FDA 3674?

The premium subscription for pdfFiller provides you with access to an extensive library of fillable forms (over 25M fillable templates) that you can download, fill out, print, and sign. You won’t have any trouble finding state-specific HHS Form FDA 3674 and other forms in the library. Find the template you need and customize it using advanced editing functionalities.

Can I sign the HHS Form FDA 3674 electronically in Chrome?

You can. With pdfFiller, you get a strong e-signature solution built right into your Chrome browser. Using our addon, you may produce a legally enforceable eSignature by typing, sketching, or photographing it. Choose your preferred method and eSign in minutes.

What is HHS Form FDA 3674?

HHS Form FDA 3674 is a form used to report information regarding clinical trials involving human subjects conducted under an investigational new drug application (IND) or investigational device exemption (IDE) in compliance with the Food and Drug Administration (FDA) regulations.

Who is required to file HHS Form FDA 3674?

The sponsors of clinical trials involving FDA-regulated products, including drugs and devices, are required to file HHS Form FDA 3674.

How to fill out HHS Form FDA 3674?

To fill out HHS Form FDA 3674, sponsors must complete the required sections regarding the study's title, IND/IDE number, principal investigator, and additional information about the trial as directed on the form.

What is the purpose of HHS Form FDA 3674?

The purpose of HHS Form FDA 3674 is to collect essential information on clinical trials to ensure compliance with regulatory requirements and to promote transparency and oversight of research involving human subjects.

What information must be reported on HHS Form FDA 3674?

HHS Form FDA 3674 requires reporting information such as the trial title, the name of the principal investigator, the IND or IDE number, and a description of the study, including any significant events or amendments.