
[Federal Register Volume 78, Number 234 (Thursday, December 5, 2013)]
[Notices]
[Page 73199]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29081]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1464]


Draft Guidance for Industry on Bioequivalence Studies With 
Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New 
Drug Application; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Bioequivalence 
Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an 
ANDA.'' This guidance provides recommendations to applicants planning 
to include bioequivalence (BE) information in abbreviated new drug 
applications (ANDAs) and ANDA supplements. The guidance describes how 
to meet the BE requirements set forth in FDA regulations. The guidance 
is applicable to dosage forms intended for oral administration and to 
non-orally administered drug products in which reliance on systemic 
exposure measures is suitable for documenting BE. The guidance will be 
especially useful when planning BE studies intended to be conducted 
during the postapproval period for certain changes in an ANDA.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 5, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, 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access to the draft guidance document.
    Submit electronic comments to http://www.regulations.gov. Submit 
written comments on the draft guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Teresa Ramson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 7520 Standish 
Pl., Rockville, MD 20855, 240-402-3870.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Bioequivalence Studies With Pharmacokinetic Endpoints for 
Drugs Submitted Under an ANDA.'' The guidance is applicable to dosage 
forms intended for oral administration, including tablets, capsules, 
solutions, suspensions, conventional/immediate release, and modified 
(extended, delayed) release drug products, and to non-orally 
administered drug products in which reliance on systemic exposure 
measures is suitable for documenting BE (e.g., transdermal delivery 
systems and certain rectal and nasal drug products).
    This guidance revises parts of the guidances to industry on 
``Bioavailability and Bioequivalence Studies for Orally Administered 
Drug Products--General Considerations,'' and ``Food-Effect 
Bioavailability and Fed Bioequivalence Studies Relating to BE studies 
in ANDAs.'' Specifically, the draft guidance revises recommendations 
related to (1) the use of systemic exposure measures and (2) 
considerations for the conduct of BE studies under fed conditions. 
Revisions are based primarily on experience gained with recommendations 
contained in prior guidances as well as on scientific information that 
has become available to the Agency. We believe the revisions will 
clarify guidance to applicants conducting BE studies for systemically 
bioavailable generic drug products. This draft guidance contains 
recommendations for submission of BE studies for ANDAs only. A separate 
guidance entitled ``Bioavailability and Bioequivalence Studies 
Submitted in NDAs or INDs--General Considerations'' to address 
investigational new drugs (INDs), new drug applications (NDAs), and NDA 
supplements will be published in the near future. FDA has determined 
that separating guidances according to application type will be 
beneficial to sponsors.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on BE studies 
with pharmacokinetic endpoints for drug products submitted in ANDAs. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that 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). Information submitted in an ANDA under 21 CFR 314.94(a)(7), 
supplemental applications submitted under 21 CFR 314.70(b), and waiver 
requests submitted under 21 CFR 314.90 are approved under OMB control 
number 0910-0001.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: November 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-29081 Filed 12-4-13; 8:45 am]
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