ARTICLE 5. New Drugs or Devices
Article 5 added by Stats. 1995, Ch. 415, Sec. 6.
§§ 111550–111610 · 12 sections
- § 111550 No person shall sell, deliver, or give away any new drug or new device unless it satisfies either of the following: (a) It is one of the following: (1) A new…
- § 111555 Within 180 days after the filing of an application provided for in Section 111550, or an additional period as shall be agreed upon by the department and the…
- § 111560 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…
- § 111565 An order pursuant to Section 111560 refusing approval of a new drug application or a new device application shall be revoked whenever the department finds that…
- § 111570 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…
- § 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…
- § 111580 When the department finds that there is an imminent hazard to the public health, it may suspend the approval for the application immediately.
- § 111585 An order pursuant to Section 111575 or 111580 withdrawing approval of an application concerning any new drug or device shall be revoked whenever the department…
- § 111590 Section 111550 does not apply to a drug or device intended solely for investigational use by experts qualified by scientific training and experience to…
- § 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…
- § 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…
- § 111610 Section 111550 does not apply to any of the following: (a) A drug or device that is sold in this state, or introduced into interstate commerce, at any time…