Investigational Drugs

The Office of Regulatory Support (ORS) provides a variety of services to support development of Investigational New Drug (IND) application submission, and provides guidance and assistance throughout the life cycle of IND-regulated studies.

An IND Training Module, designed to provide local requirements for filing an IND application as the Regulatory Sponsor and to educate on FDA requirements, is offered through Blackboard. This training will take less than an hour, and is required for any investigator who will be submitting (or who currently holds) an active IND and optional (but strongly recommended) for study coordinators and research staff involved with the submission and maintenance of an IND. Access the training.

IND a pplications will be filed with the Center for Drug Evaluation and Research (CDER) if the product is a drug and to the Center for Biologics Evaluation and Research (CBER) if the product is a biologic or a vaccine.

Services Offered:

Determination of Need

An IND application must be filed with the FDA for any clinical research that proposes the use of an unapproved drug or when clinical studies propose to use an approved drug for an off-label indication or at alternative doses.

ORS will assist in determining whether filing an IND is needed, and with the paperwork for requesting the exemption.

Exemptions:

Some clinical trials are exempt from submitting an IND.

A study may be exempt if it complies with all of the following criteria:

  • it is not intended to be reported to the FDA in support of a new indication for use or to support any other significant change in the labeling or advertising for the drug; and
  • it does not involve a change in the route of administration or dosage level, use in a subject population, or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product; and
  • it is conducted in compliance with the requirements for IRB review and does not intend to invoke exemption from informed consent; and
  • it is conducted in compliance with the requirements concerning the promotion and sale of drugs.

Guidance for pre-IND discussions with FDA

Often, the preparation of an IND application and the planning of a Study Protocol can be aided by some early advice from the FDA, in the form of a pre-IND consultation.

ORS assists in identifying any outstanding questions which would benefit from an audience with the FDA. ORS works with the researcher to assemble the pre-IND package and by participating in communications with the Regulatory Agency, as needed.

Submission of a request for a pre-IND consultation also provides an excellent opportunity to verify that the Division within the FDA selected for receipt of an IND application is the best choice for timely study review.

Assistance with submission of IND to FDA

The FDA has specified a format that the IND application should follow. Templates and support for determining what content should be included in an IND package are available from ORS.

Once the IND has been filed, the FDA acknowledges an official receipt date and assigns an IND number. The study cannot start until 30 days after the FDA receipt of the application, unless written notice from the FDA is given earlier that the study may begin. 

The FDA may request that the study not begin until additional information has been submitted to the Agency. In some cases, if the FDA determines that significant safety concerns remain, they may place the study on "Clinical Hold" until all issues have been addressed.

Assistance with filing annual reports and amendments to the FDA

As the study progresses, the Regulatory Sponsor is responsible for seeing that the study is conducted according to the current approved protocol. Changes to the protocol can be made by submitting amendments to the FDA, and ORS can assist. This FDA amendment is in addition to any related IRB requirements.

Even if no protocol changes are made, regulations require that reports be submitted to the FDA on an annual basis, at a minimum. ORS will assist with both reminding Regulatory Sponsors about reporting milestones and also in the preparation of the reports.

Adverse Event reporting is also critical to the continued operation of any clinical trial and ORS will assist researchers in abiding by the proper reporting procedures. There are several categories of adverse events and they have varying timelines for submission of the reports, based on severity.

 

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