§ 314.99. Other responsibilities of an applicant of an ANDA.
107 words·~1 min read·
/us/cfr/t21/s§ 314.99·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]
Connections3 cite this
Cited by 3 sections
Citation graph
cites case law
§ 314.99
Other responsibilities of an applicant of an ANDA.
Fed. Reg.×3
Cites 0Cited by 3 across 1 source