Drug sponsors face a long and winding path to take a drug from discovery to market.
When do you need an IND?
The IND Process
The review and approval process is overseen by the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), depending on whether the product is a drug or biologic. While the FDA distinguishes between commercial IND’s and those sought solely for research purposes, the same requirements apply equally to both categories of applicants. The IND application requires sponsors to provide information on three broad fronts, including:
- Animal Toxicology and Pharmacology Studies—Preclinical data from animal studies that indicate the drug is reasonably safe for testing in humans. This may also include other experience with the drug in humans (i.e. foreign use).
- Chemistry, Manufacturing, and Controls (CMCs)—Information that ensures the sponsor company can produce and supply the drug to market with consistency.
- Proposed Clinical Study Protocols and Investigator Information—Detailed clinical study protocols, information on the qualifications of the investigator who will oversee the clinical trial, and assurances to obtain informed consent from research subjects and to obtain the study’s review by an appropriate institutional review board (IRB).
Common IND Application Problems and How to Avoid Them
Getting the Most Out of Your Pre-IND Meeting
- The meeting objectives and a proposed agenda
- A list of specific questions categorized by discipline
- Proposed sponsor and FDA participants
- Proposed meeting date (usually 6-8 weeks out)
- When the background packet will be submitted (at least 4 weeks from the meeting date)
- Information about the quantitative composition of the drug, proposed indication, and dosing regimen