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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Clinical Hold / Refusal to File Meetings

FDA's regulations in 21 CFR part 312 provide procedures that govern the use of investigational new drugs and biologics in human subjects. If FDA determines that a proposed or ongoing study may pose significant risks for human subjects or is otherwise seriously deficient, as discussed in the regulations, it may order a clinical hold on the study. A clinical hold is an order that FDA issues to a sponsor to delay a proposed investigation or to suspend an ongoing investigation. When a proposed study is placed on clinical hold, subjects may not be given the investigational drug or biologic as part of that study. When an ongoing study is placed on clinical hold, no new subjects may be recruited to the study and placed on the investigational drug or biologic, and patients already in the study should stop receiving therapy involving the investigational drug or biologic unless FDA specifically permits it.

FDA's regulations on filing biologic license applications (BLA) are found in 21 CFR 601.2. The oversight committee conducts a review of CBER's use of its refusal to file (RTF) practices on BLAs. The committee examines all RTF decisions that occurred during the previous quarter to assess consistency across CBER offices and divisions in RTF decisions. CBER's managed review process focuses on specific milestones or intermediate goals to ensure that a quality review is conducted within a specified time period. The RTF oversight committee meetings promote the timely, efficient, and consistent review of BLAs. If there are no RTF decisions to review, the quarterly meeting may be used to review clinical holds.

The meetings of the oversight committee are closed to the public because committee discussions deal with confidential deliberations, excluding confidential commercial information. Meetings are held at CBER conference facilities in Rockville, Maryland.