FAQs

Per regulatory requirements, sponsors need an IND prior to conducting a clinical investigation with an investigational new drug that is subject to 21 CFR 312.2(a). This regulation defines what is considered an “investigational new drug,” and we suggest you review the regulation (accessible here) because an investigational new drug is not just a drug that is not marketed. It includes other definitions such as a marketed product being studied for an unapproved use, significant change in marketing, change in dose or route of administration, etc.

An IND submission can take six months to a year to prepare, so it’s best to begin the submission development process as soon as possible. If you have questions about whether you need an IND, or about the timing of the application, contact us.

The FDA welcomes conversations with sponsors as soon as they begin developing products. These engagements are held as Pre-IND Meetings with the Agency. However, these meetings are considered formal meetings and they become part of your official regulatory file. There are strict requirements for scheduling the meeting, including the format of the request, briefing packet, and meeting structure.

If you’re considering a meeting with the FDA, whether Pre-IND or for any other purpose, reach out and let Mederi help you understand your options and best prepare you for a productive meeting, leaving you with a clear path towards development.

Mederi partners with some of the best consultants in the industry in pre-clinical and CMC work, as those are critical components of the IND and development process. We contract those resources directly and manage them, so you get the best resources available while still only working through Mereri.

Yes, it’s highly recommended! When you receive your initial feedback to your questions from the FDA, you may have all the answers you think you need. However, having a meeting with the agency serves several purposes, including introducing (or re-introducing) your team and your product to the division, and discussing some responses in more detail, which can lead you to information that’s even more useful than their original feedback.

Developing your IND throughout the lifecycle of your clinical trials is constructing the building blocks of your NDA. Your work with your IND should always be with an eye towards your NDA, and it’s not limited to your regulatory documentation. Is your QMS robust enough to withstand a Pre-Approval Inspection? Have you audited your vendors thoroughly to show oversight? Have you audited your sites to ensure they’re inspection-ready? Always view your development process through the lens of your end goal of an NDA submission.

Trial registrations are required no later than 21 days after the first patient has been enrolled in an applicable clinical trial. Applicable clinical trials are (1) clinical trials of drug and biological products that are controlled, clinical investigations, other than Phase I investigations of a product subject to FDA regulations, or (2) prospective clinical studies of health outcomes comparing an intervention with a device product against a control in humans (other than small feasibility studies) or (3) any pediatric post-market surveillance studies required by FDA under the FD&C Act.

For “applicable clinical trials,” results must be posted no later than 12 months after the primary study completion date. There are possible delays of up to two additional years for trials of unapproved products for limited purposes.

A sponsor may request orphan drug designation at any time in its development process prior to the time that a marketing application submission is made for the drug for the same rare disease or condition. Orphan drug designation comes with several advantages, so it’s recommended that sponsors filed for the designation as soon as it has enough information to do so. Contact Mederi if you have questions about the orphan drug designation process, advantages, or whether the information you have is sufficient for submission.