- US Legal Forms
- Form Library
- More Forms
- More Multi-State Forms
- HHS Form FDA 3674 2023
Get HHS Form FDA 3674 2023-2024
How It Works
-
Open form follow the instructions
-
Easily sign the form with your finger
-
Send filled & signed form or save
Experience a faster way to fill out and sign forms on the web. Access the most extensive library of templates available.
Fda 3674 form FAQ
-
The Food and Drug Administration (FDA) is an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices.
-
Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (health professional) or 3500B (consumer/patient) to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
-
FDA developed Form FDA 3674 which may be used to provide certification. The certification must accompany certain human drug, biological product and device applications and submissions.
-
Form FDA 1571: Coversheet for all IND submissions. The 1571 must be signed by the Sponsor of the IND. Form FDA 1572: Statement of Investigator. The 1572 must be signed by the Principal Investigator of the clinical trial.
-
A Form FDA 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed conditions that in their judgment may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and other Acts or regulations.
-
Complete form 3454 if none of the investigators have any FDA required disclosures. Complete form 3455 if any clinical investigator has a financial disclosure that is significant.
-
What to Report on Form FDA 3500 and FDA 3500B Voluntary Adverse Event Report Form. FDA Form 3500 should be used by healthcare professionals and FDA Form 3500B should be used by patients or consumers for voluntary reporting of adverse events noted spontaneously in the course of clinical care.
-
Learn more about Clinical Trials. Drug developers, or sponsors, must submit an Investigational New Drug (IND) application to FDA before beginning clinical research.
Hhs form fda 3674 Related content
-
How to Register With Clinicaltrials.gov
Form FDA 3674 is used to certify compliance. The text above may be used in NIH...
Learn more -
Filing the IND | ResearchGo
Jun 21, 2023 — ... Form FDA 1571 (see instructions) and a ClinicalTrials.Gov...
Learn more -
FORM FDA 1571
Clinical Trials Certification of Compliance (Form FDA 3674). 2. Table of...
Learn more -
Clinical Trials Registration and Results...
Sep 21, 2016 — ... Form FDA 3674. Section 402(j)(1)(A)(iii)(I) of the PHS Act ... FDA...
Learn more -
Form FDA 3674 - Certifications To Accompany Drug...
Jul 12, 2018 — Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and...
Learn more -
ClinicalTrials.gov Requirements
Nov 13, 2018 — ▫ HHS Grant progress report - Certification that all required clinical...
Learn more -
Form FDA 3674 - Certifications To Accompany Drug...
May 29, 2020 — Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and...
Learn more -
ClinicalTrials.gov
Per instructions on Form FDA 3674, Sponsors must "provide the NCT Number ... Results...
Learn more -
Form FDA 3674--certifications to accompany drug...
Form FDA 3674--certifications to accompany drug, biological product, and device...
Learn more -
INVESTIGATIONAL NEW DRUG APPLICATION (IND)
Clinical Trials Certification of Compliance (Form FDA 3674) d. Institutional...
Learn more -
Clinical Trial Forms
Mar 7, 2022 — FDA 3674 (PDF 2.6MB) Certification of Compliance Under 42 U.S.C....
Learn more -
Formatting Requirements for IND applications
E-mail CDERAPPNUMREQUEST@fda.hhs.gov to make the request. Include in the ... Requirements...
Learn more -
Forms
382674, 0356h Instructions, Application to Market a New or Abbreviated New Drug or...
Learn more -
Best Practice for IND Exemption Studies, IND...
Oct 15, 2014 — FDA Form 3674. ▫ Requirement as of December 2007. ▫ Form is a...
Learn more -
Overview of FDAAA and Other Trial Registration...
– Certification of Compliance to FDA – Form 3674. • Form 3674 must accompany human...
Learn more -
ClinicalTrials.gov - NC TraCS Institute
Investigators holding an IND or IDE typically submit Form 3674 (pdf) to the FDA certifying...
Learn more -
Agency Information Collection Activities;...
Feb 18, 2021 — This guidance recommends the applications and submissions FDA considers...
Learn more -
Format Guidance, Standards Form And Extensions...
Certification Form (Form FDA 3674): www.fda.gov/opacom/morechoices/ fdaforms/FDA-3674.pdf...
Learn more -
IND Forms and Instructions
Mar 31, 2022 — Form FDA 3674 (PDF - 3MB): Certification of Compliance; Form FDA 3454...
Learn more -
Certification to Accompany Drug, Biological...
May 14, 2020 — This guidance recommends the applications and submissions FDA considers...
Learn more -
Chapter 16: FDA-Regulated Research
Jun 16, 2023 — Revised on: 6/16/2023. This chapter covers research involving products...
Learn more -
FORM FDA 1571
Clinical Trials Certification of Compliance (Form FDA 3674). 2. Table of...
Learn more -
ClinicalTrials.gov
Please note that an updated Form FDA 3674 providing the applicable clinical trial's NCT...
Learn more -
Investigational Device Exemption (IDE) Resources
The IDE Application submission to the FDA must also include: IDE Cover Letter;...
Learn more -
ClinicalTrials.gov
The official certification form, FDA 3674 entitled "Certification of Compliance with...
Learn more -
Clinical Trials Registration and Results...
Sep 21, 2016 — This final rule details the requirements for submitting registration and...
Learn more -
ClinicalTrials.gov - NUCats
FDA Guidance on Form FDA 3674: http://gov/RegulatoryInformation/Guidances/ucm125335.htm...
Learn more -
ClinicalTrials.gov - NC TraCS Institute
Investigators holding an IND or IDE typically submit Form 3674 (pdf) to the FDA certifying...
Learn more -
ClinicalTrials.gov FAQs
Aug 3, 2023 — See the final guidance “Form FDA 3674-Certifications to Accompany Drug...
Learn more -
IND Development Process
An academic researcher may be required to submit an IND application to the FDA in order to...
Learn more -
Form FDA 3674 - Certifications To Accompany Drug...
Jul 12, 2018 — Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and...
Learn more -
Clinical Trial Forms
Mar 7, 2022 — This page provides links to commonly used clinical trial forms relevant to...
Learn more -
Agency Information Collection Activities;...
Jun 12, 2023 — “Form FDA 3674—Certifications To Accompany Drug, Biological Product...
Learn more -
Forms
382576, 0356h, Application to Market a New or Abbreviated New Drug or Biologic for Human...
Learn more -
IND Forms and Instructions
Mar 31, 2022 — Form FDA 3674 (PDF - 3MB): Certification of Compliance; Form FDA 3454...
Learn more -
Federal Register, Volume 88 Issue 112 (Monday...
... fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has...
Learn more -
Agency Information Collection Activities;...
Feb 21, 2023 — Form FDA 3674 is a fillable PDF form and is approved for use in OMB...
Learn more -
Federal Register/Vol. 88, No. 34/Tuesday, February...
Feb 21, 2023 — Form FDA 3674 is a fillable PDF form and is approved for use in OMB...
Learn more -
Initial IND Application | Clinical Center Home...
May 8, 2023 — Form FDA 3674 - Certification of Compliance ... The Form FDA 3674 is a...
Learn more -
Federal Register, Volume 88 Issue 34 (Tuesday...
We have made Form FDA 3674 available for submitting the certification. Our estimated...
Learn more -
How to Register With Clinicaltrials.gov
Sep 16, 2016 — Form FDA 3674 is used to certify compliance. The text above may be used...
Learn more -
Filing the IND | ResearchGo
Jun 21, 2023 — ... Form FDA 1571 (see instructions) and a ClinicalTrials.Gov...
Learn more -
Good Clinical Practice and ClinicalTrials.gov...
gcp.questions@fda.hhs.gov · Replies to Previous Inquiries: https://www.fda.gov ... FDA...
Learn more -
Clinical Trials Registration and Results...
Sep 21, 2016 — ... Form FDA 3674. Section 402(j)(1)(A)(iii)(I) of the PHS Act ... FDA...
Learn more -
FORM FDA 1571
Clinical Trials Certification of Compliance (Form FDA 3674). 2. Table of...
Learn more -
ClinicalTrials.gov
Please note that an updated Form FDA 3674 providing the applicable clinical trial's NCT...
Learn more -
Formatting Requirements for IND applications
E-mail CDERAPPNUMREQUEST@fda.hhs.gov to make the request. Include in the ... Requirements...
Learn more -
ClinicalTrials.gov Requirements
Nov 13, 2018 — ▫ HHS Grant progress report - Certification that all required clinical...
Learn more -
ClinicalTrials.gov - NC TraCS Institute
Investigators holding an IND or IDE typically submit Form 3674 (pdf) to the FDA certifying...
Learn more -
ClinicalTrials.gov
The official certification form, FDA 3674 entitled "Certification of Compliance with...
Learn more -
Form FDA 3674 - Certifications To Accompany Drug...
Jul 12, 2018 — Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and...
Learn more -
Clinical Trial Forms
Mar 7, 2022 — This page provides links to commonly used clinical trial forms relevant to...
Learn more -
Forms
382576, 0356h, Application to Market a New or Abbreviated New Drug or Biologic for Human...
Learn more -
IND Forms and Instructions
Mar 31, 2022 — Form FDA 3674 (PDF - 3MB): Certification of Compliance; Form FDA 3454...
Learn more -
Abbreviated New Drug Application (ANDA) Forms and...
Oct 13, 2023 — Form FDA-3674: Certification of Compliance (instructions included) ... If...
Learn more -
Clinical Trials Guidance Documents
Form FDA 3674 — Certifications To Accompany Drug ... Radioactive Drug Research...
Learn more -
Agency Information Collection Activities;...
Jun 12, 2023 — “Form FDA 3674—Certifications To Accompany Drug, Biological Product...
Learn more -
Agency Information Collection Activities;...
Feb 21, 2023 — Form FDA 3674 is a fillable PDF form and is approved for use in OMB...
Learn more -
Federal Register/Vol. 88, No. 34/Tuesday, February...
Feb 21, 2023 — Form FDA 3674 is a fillable PDF form and is approved for use in OMB...
Learn more -
Federal Register, Volume 88 Issue 112 (Monday...
... fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has...
Learn more -
ANDA Submissions —Content and Format Guidance...
Form FDA 356h (Form 356h) – Application to Market a New or Abbreviated New...
Learn more -
Bioresearch Monitoring - Chapter 48
Sep 26, 2018 — form (Form FDA 3674) accompany certain human drug, biological, and device...
Learn more -
ANDA Submissions —Content and Format Guidance...
Form FDA 356h (Form 356h) – Application to Market a New or Abbreviated New...
Learn more -
ANDA Submissions —Content and Format Guidance...
Form FDA 356h (Form 356h) – Application to Market a New or Abbreviated New...
Learn more -
Bioresearch Monitoring - Chapter 48
Sep 26, 2018 — form (Form FDA 3674) accompany certain human drug, biological, and device...
Learn more -
Form FDA 3674 - Certifications To Accompany Drug...
Jul 12, 2018 — Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and...
Learn more -
Form FDA 3674 - Certifications To Accompany Drug...
May 29, 2020 — Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and...
Learn more -
Form FDA 3674--certifications to accompany drug...
Form FDA 3674--certifications to accompany drug, biological product, and device...
Learn more -
Clinical Trial Forms
Mar 7, 2022 — This page provides links to commonly used clinical trial forms relevant to...
Learn more -
Form FDA 3674 Certification of Compliance re...
Aug 27, 2014 — Form FDA 3674 Certification of Compliance re Amendment from The EMMES...
Learn more -
Overview of FDAAA and Other Trial Registration...
– Certification of Compliance to FDA – Form 3674. • Form 3674 must accompany human...
Learn more -
Agency Information Collection Activities;...
Feb 18, 2021 — This guidance recommends the applications and submissions FDA considers...
Learn more -
ANDA Submissions —Content and Format Guidance...
Form FDA 356h (Form 356h) – Application to Market a New or Abbreviated New...
Learn more -
Certification to Accompany Drug, Biological...
Sep 26, 2011 — This guidance identified the applications and submissions that FDA...
Learn more -
INVESTIGATIONAL NEW DRUG APPLICATION (IND)
Clinical Trials Certification of Compliance (Form FDA 3674). 2. Table of...
Learn more -
How to put together an application
FDA Form 3674-Certification of Compliance with Requirements of ClinicalTrials.gov Data...
Learn more -
FORM FDA 1571
Clinical Trials Certification of Compliance (Form FDA 3674). 2. Table of...
Learn more -
ClinicalTrials.gov
Please note that an updated Form FDA 3674 providing the applicable clinical trial's NCT...
Learn more -
Chapter 16: FDA-Regulated Research
Jun 16, 2023 — The USC HIPAA Authorization to Use Health Information for Research form...
Learn more -
Investigational Device Exemption (IDE) Resources
The IDE Application submission to the FDA must also include: IDE Cover Letter;...
Learn more -
ClinicalTrials.gov
The official certification form, FDA 3674 entitled "Certification of Compliance with...
Learn more -
Clinical Trials Registration and Results...
Sep 21, 2016 — ... Form FDA 3674. Section 402(j)(1)(A)(iii)(I) of the PHS Act ... FDA...
Learn more -
ClinicalTrials.gov - NC TraCS Institute
Investigators holding an IND or IDE typically submit Form 3674 (pdf) to the FDA certifying...
Learn more -
Clinical Trials | Human Subjects
... Human Research Studies Can Be Conducted Without an IND (FDA Guidance) ... IDE Approval...
Learn more -
ClinicalTrials.gov - NUCats
... Human Subject and Clinical Trial Information form for all proposals involving human...
Learn more -
ClinicalTrials.gov FAQs
Aug 3, 2023 — See the final guidance “Form FDA 3674-Certifications to Accompany Drug...
Learn more
Use professional pre-built templates to fill in and sign documents online faster. Get access to thousands of forms.
USLegal fulfills industry-leading security and compliance standards.
-
VeriSign secured
#1 Internet-trusted security seal. Ensures that a website is free of malware attacks.
-
Accredited Business
Guarantees that a business meets BBB accreditation standards in the US and Canada.
-
TopTen Reviews
Highest customer reviews on one of the most highly-trusted product review platforms.