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9. FDA Requirements

Investigational Drugs, Biologics, and Devices

Research involving new drugs, devices and biologics is regulated primarily by the Food and Drug Administration (FDA) and provides a transition from promising basic or laboratory research to accepted therapeutic or diagnostic procedures for patients.

Investigational drug, biologic, and device products (also called "test articles") include:

1. products that are not generally recognized as being safe and effective for any use under the conditions prescribed, recommended, or suggested by the FDA; and
2. products already approved by FDA as safe and effective for specific indications, that are being studied for new indications (or doses, strengths, or frequency) other than those that have been approved.

The Food and Drug Administration (FDA) requires IRB review and informed consent in much the same way as NIH (and other federal agencies that support research). However, FDA has several additional reporting conditions that involve investigators directly. These are described below.

INDs and IDEs

Federal law prohibits the distribution of new drugs, biologics, and medical devices until FDA has reviewed clinical data and determined that a particular product is safe and effective for a specific use in human patients. In order to test a new drug, biologic, or device in clinical trials, it is necessary to obtain an exemption from that law. Thus a drug or device sponsor is required to apply for an Investigational New Drug exemption (IND) or an Investigational Device Exemption (IDE) before tests with human subjects may begin. In general, the review requirements for biologics are the same as those for drugs. Accordingly, unless otherwise indicated, the provisions that follow use the term "drug" to apply to drugs as well as biologics. The investigator is responsible for obtaining the IND or IDE number and providing it to the HSPC.

Investigators as Sponsors

If an investigator is the developer of the drug or device and no commercial manufacturer is involved, then either the investigator or the investigator’s institution may be the sponsor for purposes of designing and organizing clinical trials. The sponsor is responsible for submitting an IND or IDE application to FDA and providing a copy of the FDA’s response to the HSPC. Sponsors also have important administrative and reporting requirements above and beyond those of investigators. Faculty contemplating the dual role of sponsor-investigator should consult with OPRS staff about the additional responsibilities that entails.

Protocol Design Requirements

Specific requirements for protocol design are set forth at [21 CFR 312.23] (drugs) and [21 CFR 812.25] (devices). See also, FDA Information Sheet (October 1995) on "Placebo-Controlled and Active-Controlled Study Designs," and [21 CFR 314.126] (Adequate and Well-Controlled Studies) (Please see "Studies of Investigational Drugs or Biologics" page 9-5 and Appendix 3,4, and 5 for more information).

Sufficiency of Animal and In Vitro Studies

The IND or IDE application must contain sufficient data from animal and in vitro studies to demonstrate the likelihood that the product will be safe and effective for the purpose indicated. If the FDA agrees that the data are sufficient to support a decision to initiate clinical trials, and that the proposed protocol is acceptable, FDA will provide an IND or IDE number for the protocol.

30-day Hold

The investigator is required to wait for 30 days after FDA receives the IND or IDE application, to permit FDA scientists to review the materials and, if necessary, request additional information, require modifications, or disapprove the application. FDA notifies the sponsor of the date it receives the IND. The HSPC will not provide formal approval for a study until the 30 days have elapsed and FDA has either provided an IND or IDE number or advised the investigator that an IND or IDE is not required [21 CFR 312.40 (b)] (drugs) and [21 CFR 812.30 (a)] (devices).

The Approved Protocol Must Be Followed

Clinical trials conducted under an IND or IDE issued by FDA are obligated to adhere to the protocol as submitted. Any modification, such as extension to another age group, use of a different dose, change in subject eligibility criteria, must be approved by FDA as well as the HSPC prior to implementation, unless immediate action is required to eliminate apparent immediate hazards to human subjects. Any changes made to eliminate an immediate hazard must be reported to the HSPC within five working days.

NOTE: Deviation from the approved protocol may subject the investigator to sanctions by the FDA and/or the HSPC, and possibly also to charges of scientific misconduct.

Records Required by FDA

The FDA regulations include specific instructions for the content of records that must be created and maintained in clinical investigations of drugs and devices [21 CFR 312.62 (drugs) and 812.40 (devices)] (Please see Appendix 3 and 5 for additional information).