C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG › Subpart C—Abbreviated Applications

21 C.F.R. § 314.99

Other responsibilities of an applicant of an ANDA

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(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]
Notes of Decisions
Cited in 1 case, 2013–2013 · leading case: Cumberland Pharm. Inc. v. Food & Drug Admin., 981 F. Supp. 2d 38 (D.D.C. 2013).
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Cumberland Pharm. Inc. v. Food & Drug Admin., 981 F. Supp. 2d 38 (D.D.C. 2013). · cites it 2× “Woodcock first notes that pursuant to 21 C.F.R. § 314.99 (b), the FDA may waive the regulatory requirement that the inactive ingredients in an injectable drug proposed in an ANDA be the same as those in the reference listed drug “as long as the statutory requirement [of 21 U.”
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