[Federal Register: July 11, 2002 (Volume 67, Number 133)]
[Notices]
[Page 45983]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jy02-73]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02D-0258]
Draft Revised Guidance for Industry on Bioavailability and
Bioequivalence Studies for Orally Administered Drug Products--General
Considerations; 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 revised guidance for industry entitled
``Bioavailability and Bioequivalence for Orally Administered Drug
Products--General Considerations.'' FDA's Biopharmaceutics Coordinating
Committee determined that a revision of the guidance was necessary as a
result of experience with implementation of the guidance, input from
the Advisory Committee for Pharmaceutical Science at a meeting held on
November 28 and 29, 2001, and changes in agency thinking based on new
data. This revision should provide better guidance to sponsors
conducting bioavailability (BA) and bioequivalence (BE) studies for
orally administered drug products.
DATES: Submit written or electronic comments on the draft revised
guidance by August 12, 2002. General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of this draft
revised guidance to the Division of Drug Information (HFD-240), Center
for Drug Evaluation and Research, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive
label to assist that office in processing your requests. Submit written
comments to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT: Aida L. Sanchez, Center for Drug
Evaluation and Research (HFD-650), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-5847.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
draft revised guidance for industry entitled ``Bioavailability and
Bioequivalence for Orally Administered Drug Products--General
Considerations.'' This document is intended to provide information to
sponsors and/or applicants planning to include BA and BE information
for orally administered drug products in investigational new drug
applications (INDs), new drug applications (NDAs), abbreviated new drug
applications (ANDAs), and their supplements. This draft revises the
guidance published as a final guidance in the Federal Register on
October 27, 2000 (65 FR 64449). It is being revised as a result of
changes in agency thinking based, in part, on input from the Advisory
Committee for Pharmaceutical Science, experience with the guidance, and
comments from industry. This draft revision of the guidance does the
following: (1) Changes recommendations for the use of replicate and
nonreplicate study designs for extended-release products and includes
recommendations regarding dissolution methods development (section III,
Methods to Document BA and BE), (2) changes to the use of only the
average BE approach for BE comparisons, (section IV, Comparison of BA
Measures in BE Studies), (3) clarifies the definitions of
proportionality (section V, Documentation of BA and BE) in the
documentation of BA and BE in response to comments from industry, (4)
changes recommendations regarding waivers of BE studies (subsection
V.C.2, Waivers of In Vivo BE Studies (Biowaivers)) in certain
situations, and (5) makes other changes such as use of the more general
term ``modified release'' as opposed to ``extended'' or ``delayed
release'' (subsections V.D.2 and V.D.3) and minor corrections to
citations of the regulations. This draft revision should provide better
guidance to sponsors conducting BA and BE studies for orally
administered drug products.
This draft revised guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft revised
guidance, when finalized, will represent the agency's current thinking
on submitting BA and BE information to INDs, NDAs, and 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.
Interested persons may submit to the Dockets Management Branch (see
ADDRESSES) written comments on the draft revised guidance. Two copies
of mailed comments are to be submitted, except that individuals may
submit one copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. This draft revised
guidance and received comments are available for public examination in
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
Persons with access to the Internet may obtain the document at
http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/
dockets/default.htm.
Dated: June 28, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-17403 Filed 7-10-02; 8:45 am]
BILLING CODE 4160-01-S