This form represents the Statement of the Investigator conducting clinical research under the IND application. Form FDA 3674. Completed by the IND Sponsor. Required for all: Initial IND applications, Protocol Amendment – New Protocol

The FDA form 3674 is a document that must accompany all FDA IND initial submissions and submission of new protocols to INDs. It is a signed statement from the sponsor-investigator that they will comply with clinicaltrials.gov requirements concerning their investigation.

Form FDA 3674 must accompany an application/submission, including certain amendments, supplements, and resubmissions, submitted under §§ 505, 515, 520(m), or 510(k) of the Federal Food, Drug, and Cosmetic Act or § 351 of the Public Health Service Act.

Form 3674 must accompany an application/submission, including amendments, supplements, and resubmissions, submitted under §§ 505, 515, 520(m), or 510(k) of the Federal Food, Drug, and Cosmetic Act or § 351 of the Public Health Service Act.

The FDA 3674 form provides essential certifications required for submitting drug, biological product, and device applications. This guidance helps sponsors, researchers, and investigations meet compliance standards.

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

A guidance document fully describes the requirements for submission of a Form 3674, and provides details of the various submissions requiring inclusion of a Form 3674. In addition you can access our quick checklist (including all the links for complete reference) by …

2021年3月3日 · ⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0910-0616 can be found here: 2021-03-03 - Extension without change of a currently approved collection

2017年6月21日 · Earlier this month, FDA updated their guidance document Form FDA 3674- certifications to accompany a drug, biological product, and device application/submissions.

Form Approved: OMB No. 0910-0616. Expiration Date: 2/28/2018. See PRA Statement below. 520(m), or 510(k) of the Federal Food, Drug, and Cosmetic Act or § 351 of the Public Health Service Act.) 1. Name of Sponsor/Applicant/Submitter. 2. Date of the Application/Submission. 3. Address. 4. Telephone and Fax Numbers. 5.