Description
This guidance is intended to assist applicants preparing to submit to the Food and Drug Administration (FDA) original 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. The guidance highlights deficiencies in relation to information about impurities that may cause FDA to refuse to receive (RTR) an ANDA. An RTR decision indicates that FDA determined that an ANDA is not sufficiently complete to permit a substantive review.
Scope & Applicability
Product Classes
4The drug product identified by the applicant for comparison; Comparison of ANDA product to RLD for pH adjuster differences
RTRT and CTD sections apply to drug products
Radioactive sterile and non-sterile drugs; Drugs with short half-lives requiring administration soon after production.
excluded from this guidance
Stakeholders
1entity submitting marketing applications
Regulatory Context
Attributes
1factor used to prioritize evaluation of at-risk drug products; Used to calculate concentration limits in ppm
Identified Hazards
Hazards
1Potentially mutagenic impurities requiring toxicity assessment.
Related CFR Sections (5)
- 21CFR314.101§ 314.101 Filing an NDA and receiving an ANDA.
(a) Filing an NDA.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 →
- 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 →
- 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 →
- 21CFR320.21§ 320.21 Requirements for submission of bioavailability and bioequivalence data.
(a) Any person submitting a full new drug application to the Food and Drug Administration (FDA) shall include in the application either:Read full regulation →
See Also (8)
- Submission of Abbreviated Reports and Synopses in Support of Marketing Applications. (Status: Final)
- Refuse to File: NDA and BLA Submissions to CDER Guidance for Industry (Status: Draft)
- Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA: Guidance for Industry (Status: Final)
- Q8, Q9, and Q10 Questions and Answers (Status: Final)
- FDA Oversight of PET Drug Products -- Questions and Answers (Status: Final)
- Analytical Procedures and Methods Validation for Drugs and Biologics (Status: Final)
- Botanical Drug Development: Guidance for Industry (Status: Final)
- ANDA Submissions -- Refuse-to-Receive Standards Rev.2 (Status: Final)