[Federal Register Volume 78, Number 234 (Thursday, December 5, 2013)]
[Notices]
[Page 73199]
From the Federal Register Online via the Government Publishing 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Draft Guidance for Industry on Bioequivalence Studies With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availability of a draft guidance for industry entitled ``Bioequivalence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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 5, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.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written comments on the draft guidance to the Division of Dockets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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