CDER SBIA Chronicles: Research Investigational New Drug Applications – What You Need to Know

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-certain-human-pharmaceutical-product-applications?utm_campaign=SBIA%20Chronicles%3A%20Research%20Investigational%20New%20Drug%20Applications&utm_medium=email&utm_source=Eloqua

Resources:

1. Providing Regulatory Submissions in Electronic Format

2. Investigator-Initiated IND webpage

3. IND Applications for Clinical Investigations: Regulatory & Administrative Components

4. FDA Forms

5. Information for Sponsor-Investigators Submitting INDs

Upcoming Events:

1. Complex Generic Drug Product Workshop – Sept. 25-26 – College Park, MD (Live webcast available)

2. Clinical Investigator Training Course (CITC) – Nov. 12-14 – College Park, MD

Research Investigational New Drug Applications - What You Need to Know

FDA recently released an update to clarify when ‘Research’ vs. ‘Commercial’ should be selected on FDA Form 1571, and thus when electronic common technical document (eCTD) requirements apply for an investigational new drug (IND) application. A commercial IND is one for which the sponsor (usually a corporate entity) intends to commercialize the product by eventually submitting a marketing application. In this case, the sponsor should select “Commercial IND” on FDA Form 1571 Field 6B.  FDA may also designate an IND as commercial if it is clear that the sponsor intends for the product to be commercialized at a later date. In comparison, a research IND (also called a non-commercial IND) is one for which the sponsor (generally an individual investigator, academic institution or non-profit entity) does not intend to later commercialize the product.  These studies are strictly for research, are usually shorter in duration and may result in publications in peer-reviewed journals. IND Application.  Commercial and research INDs are both expected to contain the following as described HERE: Cover Letter FDA Forms: 1571 – Investigational New Drug Application 1572 – Statement of Investigator 3674 - Certification of Compliance with Requirements of ClinicalTrials.gov Data Bank Table of Contents Introductory Statement and General Investigational Plan Investigator Brochure Clinical Components* Protocol Summary of Previous Human Experience with the Investigational Drug Nonclinical Components* Animal Pharmacology and Toxicology (PT) Chemistry, Manufacturing and Controls (CMC) Other information as necessary