Source: https://casetext.com/regulation/code-of-federal-regulations/title-21-food-and-drugs/chapter-i-food-and-drug-administration-department-of-health-and-human-services-continued/subchapter-d-drugs-for-human-use/part-314-applications-for-fda-approval-to-market-a-new-drug/subpart-c-abbreviated-applications/31496-amendments-to-an-unapproved-anda?ref=AsVVwS!ig2r7q
Timestamp: 2020-02-20 00:14:19
Document Index: 329614114

Matched Legal Cases: ['§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314']

§ 314.96 Amendments to an unapproved ANDA, 21 C.F.R. § 314.96 | Casetext
§ 314.96 Amendments to an unapproved ANDA
(a) ANDA. (1) An applicant may amend an ANDA that is submitted under § 314.94, but not yet approved, to revise existing information or provide additional information. Amendments containing bioequivalence studies must contain reports of all bioequivalence studies conducted by the applicant on the same drug product formulation, unless the information has previously been submitted to FDA in the ANDA. A complete study report must be submitted for any bioequivalence study upon which the applicant relies for approval. For all other bioequivalence studies conducted on the same drug product formulation as defined in § 314.3 of this chapter, the applicant must submit either a complete or summary report. If a summary report of a bioequivalence study is submitted and FDA determines that there may be bioequivalence issues or concerns with the product, FDA may require that the applicant submit a complete report of the bioequivalence study to FDA.
(b) Field copy. The applicant must submit a field copy of each amendment under § 314.94(a)(9). The applicant, other than a foreign applicant, must include in its submission of each such amendment to FDA a statement certifying that a field copy of the amendment has been sent to the applicant's home FDA district office.
(d)(1) Patent certification requirements. An amendment to an ANDA is required to contain an appropriate patent certification or statement described in § 314.94(a)(12) or a recertification for a previously submitted paragraph IV certification if approval is sought for any of the following types of amendments:
§ 314.95 Notice of certification of invalidity, unenforceability, or noninfringement of a patent
§ 314.97 Supplements and other changes to an approved ANDA