Section 111605 Of Article 5. New Drugs Or Devices From California Health And Safety Code >> Division 104. >> Part 5. >> Chapter 6. >> Article 5.
111605
. (a) In making determinations on requests for approval of
AIDS-related drugs, as defined in subdivision (b), in accordance with
Section 111550, or for exemptions from these requirements, for
purposes of investigations of these drugs, pursuant to Section
111595, the department shall employ persons to conduct reviews of
requests for drug marketing approval for AIDS-related drugs, or
exemptions from the approval requirements as specified in that
section. The AIDS Vaccine Research and Development Advisory Committee
shall review and advise the department in its actions under this
section.
Where necessary, the department shall enter into contracts with
appropriate and qualified persons or entities for the review of these
requests, including persons with significant experience in
conducting or reviewing clinical trials of drugs or physicians with
significant experience in treating AIDS patients.
No person may contract with the department for the review of a
request under this subdivision if the person has a financial interest
or a conflict of interest involving the drug being evaluated.
(b) "AIDS-related drug" means either of the following:
(1) A vaccine to protect against human immunodeficiency virus
(HIV) infection.
(2) Antiviral agent, immune modulator, or other agent to be
administered to persons who have been infected with HIV, to
counteract the effects of this infection, or any drug to treat
opportunistic infections associated with AIDS.
(c) The immunities provided for in Sections 818.4 and 821.6 of the
Government Code shall apply whenever the department grants approval
pursuant to Section 111550 or an exemption from the approval
requirements pursuant to Section 111595, for an AIDS-related drug.