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Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” This guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act) is appropriate for the submission of a marketing application to FDA. The guidance announced in this notice finalizes the draft guidance with the same name dated October 2017.
The announcement of the guidance is published in the Federal Register on May 10, 2019.
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2017-D-5974 for “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.
Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Rm. 1670, Silver Spring, MD 20993, 240-402-7930, elizabeth.giaquinto@fda.hhs.gov.
FDA is announcing the availability of a final guidance entitled ”Determining Whether to Submit an ANDA or a 505(b)(2) Application.” This guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the FD&C Act is appropriate for the submission of a marketing application to FDA. This guidance highlights criteria for submitting applications under the abbreviated approval pathways described in section 505(j) and 505(b)(2) of the FD&C Act (21 U.S.C. 355(j) and 21 U.S.C. 355(b)(2), respectively), identifies considerations to help potential applicants determine whether an application would be more appropriately submitted under section 505(j) or pursuant to section 505(b)(2) of the FD&C Act, and provides direction to potential applicants on requesting assistance from FDA in making this determination.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the Hatch-Waxman Amendments) added section 505(b)(2) and 505(j) of the FD&C Act, which describe abbreviated approval pathways for drug products regulated by the Agency under the FD&C Act. The Hatch-Waxman Amendments reflect Congress's efforts to balance the need to “make available more low cost generic drugs by establishing a generic drug approval procedure” with new incentives for drug development in the form of exclusivities and patent term extensions. With the passage of the Hatch-Waxman Amendments, the FD&C Act describes different routes for obtaining approval of two broad categories of drug applications: New drug applications (NDAs) and abbreviated new drug applications (ANDAs).
This guidance focuses on those applications that can be submitted as ANDAs under section 505(j) of the FD&C Act, petitioned ANDAs under section 505(j)(2)(C) of the FD&C Act, or NDAs pursuant to section 505(b)(2) of the FD&C Act. This guidance does not discuss stand-alone NDAs.
In the Federal Register of October 13, 2017 (82 FR 47749), FDA announced the availability of the draft guidance of the same title dated October 2017. FDA received four comments on the draft guidance and those comments were considered as the guidance was finalized. We note that we received comments requesting clarification on the process for obtaining therapeutic equivalence evaluations. We will address therapeutic equivalence in a forthcoming guidance document (see “Guidance Agenda: New and Draft Guidances CDER Plans to Publish During Calendar Year 2019”). The final guidance contains minor clarifications to the draft guidance. The guidance announced in this notice finalizes the draft guidance dated October 2017.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 314.94 have been approved under OMB control number 0910-0001. The collection of information for controlled correspondence and pre-ANDA meeting requests has been approved under OMB control number 0910-0797.
Persons with access to the internet may obtain the guidance at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: May 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09662 Filed 5-9-19; 8:45 am]
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