Failure to take action. (1) An appli- cant agrees to extend the review period under section 505(c)(1) or (j)(5)(A) of the act until it takes any of the actions listed in paragraph (b) of this section. For an application or abbreviated ap- plication, FDA may consider an appli- cant’s failure to take any of such ac- tions within 1 year after issuance of a complete response letter to be a re- quest by the applicant to withdraw the application, unless the applicant has requested an extension of time in
Appears in 2 contracts
Sources: Abbreviated Application Resubmission Agreement, Abbreviated Application Resubmission Agreement