To get your drug into clinical trials in the United States, you first need to obtain Investigational New Drug (IND) approval from the FDA (Food and Drug Administration).
This may sound simple, but even getting to the stage of applying for approval can take a long time. Your chemists, clinicians, and scientists will have to work together to produce an appropriate drug candidate that warrants testing on humans. You will also have to develop a robust argument supporting the safe dosing of human subjects.
This being said, obviously, the sooner you can get clinical trials of your drug started in the US, the sooner you will potentially be able to make progress. . ONIX can support you by ensuring your IND submission contains all the required information and is error-free.
What is an Investigational New Drug Application (IND)?
Thomson Reuters Practical Law defines an Investigational New Drug Application (IND) as: "An application to the Food and Drug Administration (FDA) for human clinical studies of an unapproved drug or biologic. An Investigational New Drug Application (IND) is a request for an exemption from the Food, Drug and Cosmetic Act's prohibition against introducing an unapproved drug into interstate commerce."
They go on to say that the IND must include, amongst other things:
- A protocol for a proposed clinical study, the qualifications of the investigators conducting it
- Information on the drug's chemistry, manufacturing and controls
- Preclinical, pharmacological and toxicological data to demonstrate the drug is reasonably safe to test on humans
What forms of IND are there?
There are two different forms of IND, and they are:
- Commercial IND - a corporate entity will file a commercial IND if they have plans to commercialise the product. Commercial INDs must be submitted in an electronic format (eCTD).
- Research IND (also known as a non-commercial IND) - is filed when the sponsor does not intend to commercialise the product, as the product is for research purposes only. Although electronic submission standards are encouraged for research INDs, they are optional.
How is an IND application submitted?
An IND application is expected to contain the following information:
- Cover Letter
- Three FDA Forms - Form 1571 (Investigational New Drug Application), Form 1572 (Statement of Investigator) and Form 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 and 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)
These requirements can be hard to understand, as they are pretty complicated. This is why working with an experienced team of consultants can help to ensure you have access to the knowledge needed and are on track to deliver a successful application. The team at ONIX will work closely with you to ensure your IND application meets the stringent IND filing requirements of the FDA.
ONIX will guide you through every step of the IND application process and ensure your application is error-free. Please contact us today to learn more about how we can help you submit a successful IND application to the FDA.