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 D—FDA Action on Applications and Abbreviated Applications

21 C.F.R. § 314.110

Complete response letter to the applicant

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(a) Complete response letter. FDA will send the applicant a complete response letter if the agency determines that we will not approve the application or abbreviated application in its present form for one or more of the reasons given in § 314.125 or § 314.127, respectively.

(1) Description of specific deficiencies. A complete response letter will describe all of the specific deficiencies that the agency has identified in an application or abbreviated application, except as stated in paragraph (a)(3) of this section.

(2) Complete review of data. A complete response letter reflects FDA's complete review of the data submitted in an original application or abbreviated application (or, where appropriate, a resubmission) and any amendments that the agency has reviewed. The complete response letter will identify any amendments that the agency has not yet reviewed.

(3) Inadequate data. If FDA determines, after an application is filed or an abbreviated application is received, that the data submitted are inadequate to support approval, the agency might issue a complete response letter without first conducting required inspections and/or reviewing proposed product labeling.

(4) Recommendation of actions for approval. When possible, a complete response letter will recommend actions that the applicant might take to place the application or abbreviated application in condition for approval.

(b) Applicant actions. After receiving a complete response letter, the applicant must take one of following actions:

(1) Resubmission. Resubmit the application or abbreviated application, addressing all deficiencies identified in the complete response letter.

(i) A resubmission of an application or efficacy supplement that FDA classifies as a Class 1 resubmission constitutes an agreement by the applicant to start a new 2-month review cycle beginning on the date FDA receives the resubmission.

(ii) A resubmission of an application or efficacy supplement that FDA classifies as a Class 2 resubmission constitutes an agreement by the applicant to start a new 6-month review cycle beginning on the date FDA receives the resubmission.

(iii) A resubmission of an NDA supplement other than an efficacy supplement constitutes an agreement by the applicant to start a new review cycle the same length as the initial review cycle for the supplement (excluding any extension due to a major amendment of the initial supplement), beginning on the date FDA receives the resubmission.

(iv) A major resubmission of an abbreviated application constitutes an agreement by the applicant to start a new 6-month review cycle beginning on the date FDA receives the resubmission.

(v) A minor resubmission of an abbreviated application constitutes an agreement by the applicant to start a new review cycle beginning on the date FDA receives the resubmission.

(2) Withdrawal. Withdraw the application or abbreviated application. A decision to withdraw an application or abbreviated application is without prejudice to a subsequent submission.

(3) Request opportunity for hearing. Ask the agency to provide the applicant an opportunity for a hearing on the question of whether there are grounds for denying approval of the application or abbreviated application under section 505(d) or (j)(4) of the act, respectively. The applicant must submit the request to the Associate Director for Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993. Within 60 days of the date of the request for an opportunity for a hearing, or within a different time period to which FDA and the applicant agree, the agency will either approve the application or abbreviated application under § 314.105, or refuse to approve the application under § 314.125 or abbreviated application under § 314.127 and give the applicant written notice of an opportunity for a hearing under § 314.200 and section 505(c)(1)(B) or (j)(5)(c) of the act on the question of whether there are grounds for denying approval of the application or abbreviated application under section 505(d) or (j)(4) of the act, respectively.

(c) Failure to take action. (1) An applicant 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 application, FDA may consider an applicant's failure to take any of such actions within 1 year after issuance of a complete response letter to be a request by the applicant to withdraw the application, unless the applicant has requested an extension of time in which to resubmit the application. FDA will grant any reasonable request for such an extension. FDA may consider an applicant's failure to resubmit the application within the extended time period or to request an additional extension to be a request by the applicant to withdraw the application.

(2) If FDA considers an applicant's failure to take action in accordance with paragraph (c)(1) of this section to be a request to withdraw the application, the agency will notify the applicant in writing. The applicant will have 30 days from the date of the notification to explain why the application should not be withdrawn and to request an extension of time in which to resubmit the application. FDA will grant any reasonable request for an extension. If the applicant does not respond to the notification within 30 days, the application will be deemed to be withdrawn.

[73 FR 39609, July 10, 2008]
Notes of Decisions
Cited in 24 cases (6 in the last 5 years), 1977–2025 · leading case: Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019).
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Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019). · cites it 3× “The FDA explained that Merck's "justification" for the proposed change to the Precautions section was "inadequate," because "[i]dentification of 'stress fractures ' may not be clearly related to the atypical subtrochanteric fractures that have been reported in the literature.”
Nostrum Pharm. LLC v. FDA, 35 F.4th 820 (D.C. Cir. 2022). · cites it 11× “” 21 C.F.R. § 314.110 (a)(1), (4). If the applicant’s responses would “require extensive assessment[,]” the agency categorizes them as “major” amendments.”
Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1688 (2019). · cites it 3× “, at 512; see 21 CFR §314.110 (b). But Merck instead withdrew its application and decided to make the changes to the Ad- verse Reactions section through the CBE process.”
Pharm. Mfg. Rsch. Servs., Inc. v. FDA, 957 F.3d 254 (D.C. Cir. 2020). · cites it 3× “See 21 C.F.R. § 314.110 (a) (describing 5 FDA process for complete response letters).”
In Re Fosamax (Alendronate Sodium) Prods. Liab. Litig., 852 F.3d 268 (3rd Cir. 2017). “21 C.F.R. § 314.110 (a). Plaintiffs claim that since the May 2009 FDA response letter did not mention any concern over the scientific evidence of a causal association between Fosamax and fractures, we can determine as a matter of law that the FDA would have accepted a proposal…”
Mills v. Warner-Lambert Co., 581 F. Supp. 2d 772 (E.D. Tex. 2008). · cites it 2× “Cartwright, at 879 (citing 21 C.F.R. § 314.110 (a)). Id. What’s more, “[a]pproval of the NDA is ‘conditioned upon the applicant incorporating the specified labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed labeling prior…”
In Re: Ocular Therapeutix Inc v., 955 F.3d 194 (1st Cir. 2020). “21 C.F.R. § 314.110 . The CRL rejecting the NDA for Dextenza was neither publicly released nor entered into the record of this proceeding.”
Horne v. Novartis Pharm. Corp., 541 F. Supp. 2d 768 (W.D.N.C. 2008). “21 C.F.R. § 314.110 (a). Before reaching a final decision on the NDA, the FDA will convene an advisory committee to consider the NDA and the FDA’s analysis of it.”
CareToLive v. Von Eschenbach, 525 F. Supp. 2d 938 (S.D. Ohio 2007). “43351 , 43352 (July 20, 2004) (to be codified at 21 C.F.R. §§ 314.110 , 314.120). C. Statement of Facts Provenge is a biological product intended to treat a particular type of metastatic prostate cancer.”
Caretolive v. Von Eschenbach, 525 F. Supp. 2d 952 (S.D. Ohio 2007). “43351 , 43352 (July 20, 2004) (codified at 21 C.F.R. §§ 314.110 , 314.120). C. Statement of Facts Provenge is a biological product intended to treat a particular type of metastatic prostate cancer.”
Smithkline Corp. v. Food & Drug Admin., 587 F.2d 1107 (D.C. Cir. 1978). “5 (d) (1973), now codifíed at 21 C.F.R. § 314.110 (d). . The necessity for such a broad notice was spelled out in FDA regulations: The Food and Drug Administration’s conclusions on the effectiveness of drugs are currently being published in the Federal Register as Drug Efficacy…”
Parke, Davis & Co. v. Califano, 564 F.2d 1200 (6th Cir. 1977). “Parke Davis protested the September 8, 1976 notice that its supplemental NDA was not approvable, following procedures prescribed in 21 CFR § 314.110 (d). On November 22,1976 the appropriate officer at FDA signed a notice of proposed denial of Parke Davis’ supplemental NDA which…”
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