ANDA Submissions -- Refuse-to-Receive Standards Rev.2

Description

This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) to ANDAs for which the applicant is seeking approval of a new strength of the drug product.2 The guidance highlights deficiencies that may cause FDA to refuse to receive (RTR) an ANDA.3 An RTR decision indicates that FDA determined that an ANDA is not substantially complete.4 A substantially complete ANDA is “an ANDA that on its face is sufficiently complete to permit a substantive review.”5

Scope & Applicability

Regulatory Context

• 21CFR314.94§ 314.94 Content and format of an ANDA.

  ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →

• 21CFR314.101§ 314.101 Filing an NDA and receiving an ANDA.

  (a) Filing an NDA.Read full regulation →

• 21CFR73.1200§ 73.1200 Synthetic iron oxide.

  (a) Identity.Read full regulation →

• 21CFR25.31§ 25.31 Human drugs and biologics.

  The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:Read full regulation →

• 21CFR25.15§ 25.15 General procedures.

  (a) All applications or petitions requesting agency action require the submission of an EA or a claim of categorical exclusion. A claim of categorical exclusion shall include a statement of compliance with the categorical exclusion criteria and shall state that to the applicant's knowledge, no extraRead full regulation →

• 21CFR314.103§ 314.103 Dispute resolution.

  (a) General. FDA is committed to resolving differences between applicants and FDA reviewing divisions with respect to technical requirements for applications or abbreviated applications as quickly and amicably as possible through the cooperative exchange of information and views.Read full regulation →

• 21CFR320.22§ 320.22 Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.

  (a) Any person submitting a full or abbreviated new drug application, or a supplemental application proposing any of the changes set forth in § 320.21(c) , may request FDA to waive the requirement for the submission of evidence measuring the in vivo bioavailability or demonstrating the in vivo bioeqRead full regulation →

• 21CFR314.3§ 314.3 Definitions.

  (a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter .Read full regulation →

• 21CFR314.93§ 314.93 Petition to request a change from a listed drug.

  (a) The only changes from a listed drug for which the agency will accept a petition under this section are those changes described in paragraph (b) of this section. Petitions to submit ANDAs for other changes from a listed drug will not be approved.Read full regulation →

• 21CFR314.50§ 314.50 Content and format of an NDA.

  NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →

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