Jurris.COM
Section 111595 Of Article 5. New Drugs Or Devices From California Health And Safety Code >> Division 104. >> Part 5. >> Chapter 6. >> Article 5.
111595
. Section 111550 does not apply to any drug or device
intended solely for investigational use by experts qualified by
scientific training and experience to investigate the safety and
effectiveness of drugs or devices if all the following conditions are
complied with:
(a) The submission to the department, before any clinical testing of a drug or device is undertaken, of reports, by the manufacturer or the sponsor of the investigation of the drug or device, of preclinical tests including tests on animals, of the drug or device adequate to justify the proposed clinical testing.
(b) The manufacturer or the sponsor of the investigation of a drug or a device proposed to be distributed to investigators for clinical testing obtaining a signed, notarized agreement from each of the investigators that patients to whom the drug or device is administered will be under his or her personal supervision, or under the supervision of investigators responsible to him or her, and that he or she will not supply the drug or device to any other investigator, or to clinics, for administration to human beings.
(c) The establishment and maintenance of the records, and the making of the reports to the department, by the manufacturer or the sponsor of the investigation of the drug or device, of data, including but not limited to, analytical reports by investigators, obtained as a result of the investigational use of the drug or device, as the department finds will enable it to evaluate the safety and effectiveness of the drug or device in the event of the filing of an application pursuant to Section 111550.
(d) The manufacturer, or the sponsor of the investigation, require experts using the drugs or devices for investigational purposes to certify to the manufacturer or sponsor that they will comply with the requirements of Article 4 (commencing with Section 111515).
(e) Any other conditions as the department shall adopt as regulations necessary for the protection of the public health. The federal regulations adopted pursuant to Section 505(i) of the federal act (21 U.S.C. Sec. 355(i)) or Section 520(g) thereof (21 U.S.C. Secs. 352 and 360) shall be the regulations for exemptions from Section 111550 in this state. However, the department may prescribe, by regulation, any condition for exemption from Section 111550 whether or not the condition is in accordance with regulations adopted under the federal act.
(a) The submission to the department, before any clinical testing of a drug or device is undertaken, of reports, by the manufacturer or the sponsor of the investigation of the drug or device, of preclinical tests including tests on animals, of the drug or device adequate to justify the proposed clinical testing.
(b) The manufacturer or the sponsor of the investigation of a drug or a device proposed to be distributed to investigators for clinical testing obtaining a signed, notarized agreement from each of the investigators that patients to whom the drug or device is administered will be under his or her personal supervision, or under the supervision of investigators responsible to him or her, and that he or she will not supply the drug or device to any other investigator, or to clinics, for administration to human beings.
(c) The establishment and maintenance of the records, and the making of the reports to the department, by the manufacturer or the sponsor of the investigation of the drug or device, of data, including but not limited to, analytical reports by investigators, obtained as a result of the investigational use of the drug or device, as the department finds will enable it to evaluate the safety and effectiveness of the drug or device in the event of the filing of an application pursuant to Section 111550.
(d) The manufacturer, or the sponsor of the investigation, require experts using the drugs or devices for investigational purposes to certify to the manufacturer or sponsor that they will comply with the requirements of Article 4 (commencing with Section 111515).
(e) Any other conditions as the department shall adopt as regulations necessary for the protection of the public health. The federal regulations adopted pursuant to Section 505(i) of the federal act (21 U.S.C. Sec. 355(i)) or Section 520(g) thereof (21 U.S.C. Secs. 352 and 360) shall be the regulations for exemptions from Section 111550 in this state. However, the department may prescribe, by regulation, any condition for exemption from Section 111550 whether or not the condition is in accordance with regulations adopted under the federal act.
