499.022  Technical review; approvals and denials.--

(1)  The technical panel shall review each investigational drug application and, based on the information provided by the applicant under s. 499.018, shall recommend approval or denial to the Secretary of ¹Health and Rehabilitative Services.

(2)  An application for the manufacture, use, distribution, or repackaging of an investigational drug becomes effective 120 days after the filing for application with the department for review by the technical panel, if the panel has not made its recommendation for approval or denial to the secretary. After due notice to the applicant and the opportunity for administrative hearing in accordance with the provisions of chapter 120, the department may issue an order refusing to permit the application to become effective.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; s. 6, ch. 87-50; ss. 8, 13, 14, ch. 88-159; s. 5, ch. 91-429; s. 25, ch. 92-69.