California Health and Safety Code

§ 109320

HSC § 109320 Effective Jan 1, 1996Div. 104 · Part 4 · Ch. 4 · Art. 2

Statute text

(a)The board shall issue an order withdrawing approval of an application concerning any drug, medicine, compound, or device if, after due notice to the applicant and opportunity for a hearing, the board finds any of the following:

(1)That clinical or other experience, tests, or other scientific data show that the drug, medicine, compound, or device is unsafe for use under the conditions of use upon the basis that the application was approved;

(2)That new evidence of clinical experience, not contained in the application or not available to the board until after the application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when the application was approved, evaluated together with the evidence available to the board when the application was approved, shows that the drug, medicine, compound, or device is not shown to be safe for use under conditions of use upon the basis that the application was approved; or

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Legislative history

Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.