California Health and Safety Code

§ 111575

HSC § 111575 Effective Jan 1, 1996Div. 104 · Part 5 · Ch. 6 · Art. 5

Statute text

The department shall issue an order withdrawing approval of an application concerning any new drug or device if, after giving written notice to the applicant and an opportunity for a hearing, the department makes any of the following findings:

(a)That clinical or other experience, tests, or other scientific data show that the new drug or device is unsafe for use under the conditions of use upon the basis of which the application was approved.

(b)That new evidence of clinical experience, not contained in the application or not available to the department 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 department when the application was approved, shows that the new drug or device is not shown to be safe for use under the conditions of use upon the basis of which the application was approved.

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Legislative history

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