(a) An applicant must comply with the requirements of §314.65 regarding withdrawal by the applicant of an unapproved ANDA and §314.72 regarding a change in ownership of an ANDA.

(b) An applicant may ask FDA to waive under this section any requirement that applies to the applicant under §§314.92 through 314.99. The applicant must comply with the requirements for a waiver under §314.90. If FDA grants the applicant's waiver request with respect to a requirement under §§314.92 through 314.99, the waived requirement will not constitute a basis for refusal to approve an ANDA under §314.127.

81 FR 69653, Oct. 6, 2016]