Studies using an investigational drug (not FDA-approved) in a clinical study are regulated by the Food and Drug Administration (FDA). Additionally, some studies testing FDA-approved drugs when used in and investigational way (“off-label”, new patient population, new dosage, new route of administration, etc.) are also regulated by the FDA. Specific requirements regarding the development, manufacturing, documentation, as well as other specific requirements may be needed to comply with the FDA regulations and law. Therefore, we offer support to Georgia Tech faculty, students, and staff in complying with all applicable regulations and laws. Please see the FAQs below for more detail.
What is considered to be a drug?
The FDA defines a medical device in Section 201(g) of the Food, Drug, and Cosmetic Act as:
- A substance recognized by an official pharmacopoeia or formulary.
- A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
- A substance (other than food) intended to affect the structure or any function of the body.
- A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.
- Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process.)
What is considered to be a biologic?
The FDA definition of Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources — human, animal, or microorganism — and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.
When should I get Regulatory Affairs involved?
It is highly recommended to engage with the Regulatory Affairs and Clinical Trials team early on in the study design process. The Regulatory Affairs and Clinical Trials team can identify possible challenges that may need to be addressed prior to submitting funding proposals and/or submitting to the IRB for review. Thees challenges can both delay the start of the study and add unexpected costs.
Does my study need an IND?
When an investigational drug (not FDA-approved) is being used in a clinical study, an IND is required. When an FDA-approved drug is being used in an investigational manner (“off-label”--different patient population, dose, route of administration, etc.), an IND may be required depending on whether the study meets the IND exemption criteria. The IRB will determine if an IND is needed during the study protocol’s review, but the Regulatory Affairs and Clinical Trials team can provide a preliminary assessment when requested.
Who submits an IND to the FDA?
The Principal Investigator, a regulatory coordinator, the sponsor, or another designated study team member can create the IND submission for FDA review. However, the Regulatory Affairs and Clinical Trials team must review and submit all Georgia Tech sponsored INDs and subsequent reports, supplements, and amendments to the FDA.
How does Regulatory Affairs support the IRB process?
The Regulatory Affairs and Clinical Trials team does not submit IRB submissions on behalf of the study team. However, we are available for both in-person and virtual meetings to work through the submission and provide support when completing the submission and responding to the IRB.
How does Regulatory Affairs support the manufacturing process?
Georgia Tech does not have a dedicated Good Manufacturing Practices (GMP) Quality team. Therefore, drugs and biologics will need to be manufactured at an appropriate facility that complies with all of the relevant GMP requirements. The IND sponsor or a qualified delegate should review and store all documentation from the manufacturing process and any analytical testing. Please share manufacturing and testing information with the Regulatory Affairs and Clinical Trials team so that required information can be submitted to the IND.
When do I report adverse events to the FDA?
Serious and unexpected suspected adverse reactions must be submitted to the IND in addition to the IRB. If they are fatal or life-threatening, they must be submitted within 7 calendar days, and all other serious suspected adverse reactions must be submitted within 15 calendar days. If an SAE occurs that could possibly be related to the investigational drug, loop in the Regulatory Affairs and Clinical Trials team ASAP for awareness. Our team can help the team with assessing whether the adverse event is considered “unexpected”. This assessment is required to be made based on the risk information provided to the FDA within the IND, protocol, and consent, not just based on the PI’s assessment on whether it is expected for the disease or drug. An adverse event or suspected adverse reaction is considered “unexpected” if it is not listed in the investigator brochure or is not listed at the specificity or severity that has been observed; or, if an investigator brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere in the current IND application.
Does Regulatory Affairs help with FDA meeting submissions?
Yes, the Regulatory Affairs and Clinical Trials team supports Pre-IND Meetings and any subsequent meetings. A Pre-IND Meeting can also provide information that will assist sponsors in preparing to submit complete investigational new drug (IND) applications and reduce the risk of a clinical hold. The primary purpose of this meeting is to review and obtain feedback on the design of preclinical studies, the design of the initial IND study, and product manufacturing and quality controls needed to initiate human studies. The meeting also provides an opportunity to discuss the plans for studying the product in pediatric populations, the target product profile, the quality target product profile, the design and results of any natural history studies, and the best approach for presentation and formatting of data in the IND. Please contact us as soon as possible if you would like to submit a meeting request to the FDA. The Regulatory Affairs and Clinical Trials team must review and submit all GT-sponsored FDA meeting requests.
Does Regulatory Affairs help with marketing applications?
As employees of a nonprofit research university, the Regulatory Affairs and Clinical Trials team's focus is on supporting research rather than marketing applications. If you believe support of your marketing application is within GT’s mission, please reach out to us for further discussion.