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FDA Approval

If you plan on conducting human subjects research at LBNL involving an experimental drug or device, additional requirements will apply.

Radioactive drugs utilized for research purposes may fall under the purview of the Berkeley Lab Radioactive Drug Research Committee. The RDRC operates under the authority of the federal Food and Drug Administration (FDA); their governing regulations can be found at : their site . .

Contact Dr. Rebecca Abergel, Chair of the RDRC, or the HARC office staff (x5399) for assistance in determining whether the protocol requires RDRC review.

Researchers using radioactive drugs must file four quarterly and one annual reports on studies conducted using the new drug. See the RDRC website to download the necessary forms and to see the 2011 due dates for these reports.

New drugs being tested to establish efficacy, toxicity or dose must be covered under an Investigational New Drug exemption (IND), from the US Food and Drug Administration. Go to the FDA Investigational New Drug website directly with questions, or contact the HARC Program Analyst (x5399) here at the Lab for assistance. Drugs available for Lab use only under existing INDs held by other investigators will also require special review.

If you plan to use an experimental device, including diagnostic devices, an Investigational Device Exemption (IDE) is required. You may go to the FDA Investigational Device Exemption website directly with questions; or contact the HARC office staff(x5399) here at the Lab to assist you.