In the case of any new drug or device for which an approval of an application filed pursuant to Section 111550 is in effect, the applicant shall establish and maintain records, and make reports to the department, of data relating to clinical experience and other data or information, received or otherwise obtained by the applicant with respect to the new drug or device, as the department may by general regulation, or by order with respect to the application, prescribe. Any regulation or order issued pursuant to this section or pursuant to Section 111595 shall have due regard for the professional ethics of the medical profession and the interest of patients and shall provide, where the department determines that it is reasonably necessary, for the examination upon request, by the persons to whom the regulation or order is applicable, of similar information received or otherwise obtained by the department. Every person required pursuant to this section to maintain records, and every person in charge or in custody of the records, shall, upon request of an authorized agent of the department, permit the agent at all reasonable time to have access to, and copy and verify, the records.
(Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)