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1999 Florida Statutes

499.021  Authority and duties of the technical panel.--The technical panel shall have the authority to make recommendations to the department on applications submitted pursuant to s. 499.018. The duties of the technical panel include, but are not limited to, reviewing and making recommendations relating to:

(1)  The need for or use of consulting contracts for scientific evaluation or analysis of an investigational drug for which an application has been submitted.

(2)  The need for or use of consulting contracts for evaluations on the continuance, revision, or termination of investigational drug product permits and for monitoring an investigational drug for which an application has been submitted.

(3)  The need for and use of consulting contracts for preparation of executive summaries of an application for approval of an investigational drug.

(4)  The use and approval of laboratory facilities to analyze investigational drugs.

(5)  The establishment of label and labeling requirements for investigational drugs.

(6)  The information required for applications and registrations of investigational drugs.

(7)  The approval or denial of investigational drug applications.

(8)  Matters referred to it by the department.

History.--s. 34, ch. 82-225; s. 2, ch. 83-265; s. 87, ch. 85-81; ss. 7, 13, 14, ch. 88-159; s. 5, ch. 91-429; s. 24, ch. 92-69.