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Section 111575 Of Article 5. New Drugs Or Devices From California Health And Safety Code >> Division 104. >> Part 5. >> Chapter 6. >> Article 5.
111575
. 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.
(c) On the basis of new information with respect to the new drug or device, evaluated together with the evidence available to the department when the application was approved, that there is a lack of substantial evidence that the new drug or device will have the effect it purports or is represented to have, under the conditions of use prescribed, recommended, or suggested in the labeling or advertising of the new drug or device.
(d) That the application contains any untrue statement of a material fact.
(e) That the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain the records or to make required reports, or the applicant has refused to permit access to, or copying or verification of, the records.
(f) That on the basis of new information before the department, evaluated together with the evidence before it when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the new drug or device are inadequate to assure and preserve its identity, strength, quality, purity, composition, and characteristics as determined by qualified experts selected by the department, and were not made adequate within a reasonable time after receipt of written notice from the department specifying the matter complained of.
(g) That on the basis of new information before it, evaluated together with the evidence before it when the application was approved, the labeling or advertisement of the new drug or device, based on an evaluation of all material facts, is false or misleading in any particular and is not corrected within a reasonable time after receipt of written notice from the department specifying the matter complained of.
(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.
(c) On the basis of new information with respect to the new drug or device, evaluated together with the evidence available to the department when the application was approved, that there is a lack of substantial evidence that the new drug or device will have the effect it purports or is represented to have, under the conditions of use prescribed, recommended, or suggested in the labeling or advertising of the new drug or device.
(d) That the application contains any untrue statement of a material fact.
(e) That the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain the records or to make required reports, or the applicant has refused to permit access to, or copying or verification of, the records.
(f) That on the basis of new information before the department, evaluated together with the evidence before it when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the new drug or device are inadequate to assure and preserve its identity, strength, quality, purity, composition, and characteristics as determined by qualified experts selected by the department, and were not made adequate within a reasonable time after receipt of written notice from the department specifying the matter complained of.
(g) That on the basis of new information before it, evaluated together with the evidence before it when the application was approved, the labeling or advertisement of the new drug or device, based on an evaluation of all material facts, is false or misleading in any particular and is not corrected within a reasonable time after receipt of written notice from the department specifying the matter complained of.
