California Health and Safety Code

§ 111560

HSC § 111560 Effective Jan 1, 1996Div. 104 · Part 5 · Ch. 6 · Art. 5

Statute text

The department shall issue an order refusing to approve an application if, after written notice to the applicant and after giving him or her an opportunity for a hearing, the department makes any of the following findings:

(a)That the reports of investigation, that are required to be submitted to the department pursuant to Section 111550, do not include adequate tests by all methods reasonably applicable to show whether or not the new drug or device is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling and advertisement of the new drug or device.

(b)That the results of the tests submitted pursuant to Section 111550 to show whether or not the new drug or device is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling and advertisement of the new drug or device show that the drug or device is unsafe for use under these conditions or do not show that the new drug or device is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling and advertisement.

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Legislative history

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