Jurris.COM
Section 111555 Of Article 5. New Drugs Or Devices From California Health And Safety Code >> Division 104. >> Part 5. >> Chapter 6. >> Article 5.
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 applicant, the department shall do
either of the following:
(a) Approve the application, if it finds that none of the grounds for denying approval specified in Section 111550 apply.
(b) Give the applicant written notice for an opportunity for a hearing before the department on the question of whether the application is approvable. If the applicant elects to accept the opportunity for hearing by written request within 30 days after the notice, the hearing shall commence not more than 90 days after the expiration of the 30 days unless the department and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the department's order thereon shall be issued within 90 days after the date fixed by the department for filing final briefs.
(a) Approve the application, if it finds that none of the grounds for denying approval specified in Section 111550 apply.
(b) Give the applicant written notice for an opportunity for a hearing before the department on the question of whether the application is approvable. If the applicant elects to accept the opportunity for hearing by written request within 30 days after the notice, the hearing shall commence not more than 90 days after the expiration of the 30 days unless the department and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the department's order thereon shall be issued within 90 days after the date fixed by the department for filing final briefs.
