Draft Guidance for Industry on Bioequivalence Recommendations for Specific Products, 30388-30390 [E7-10492]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 104 (Thursday, May 31, 2007)]
[Notices]
[Pages 30388-30390]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10492]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0169]


Draft Guidance for Industry on Bioequivalence Recommendations for 
Specific Products

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availability of a draft guidance for industry entitled ``Bioequivalence 
Recommendations for Specific Products'' that describes a new process 
for making available recommendations on how to design product-specific 
bioequivalence (BE) studies to support abbreviated new drug 
applications (ANDAs). Under this process, applicants planning to carry 
out such studies in support of their ANDAs will be able to access BE 
study guidance on the FDA Web site. FDA believes that making this 
information available on the Internet

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will streamline the guidance process and will provide a meaningful 
opportunity for the public to consider and comment on product-specific 
BE study recommendations. Elsewhere in this issue of the Federal 
Register, FDA is announcing the availability of the first group of 
draft product-specific BE recommendations.

DATES: Submit written or electronic comments on the draft guidance by 
August 29, 2007. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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 
on the draft guidance to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to https://www.fda.gov/dockets/
ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Doan T. Nguyen, Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0495.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Bioequivalence Recommendations for Specific Products.'' To 
receive approval for an ANDA, an applicant generally must demonstrate, 
among other things, that its product has the same active ingredient, 
dosage form, strength, route of administration and conditions of use as 
the listed drug, and that the proposed drug product is bioequivalent to 
the reference listed drug (21 U.S.C. 355(j)(2)(A); 21 CFR 314.94(a)). 
Bioequivalent drug products show no significant difference in the rate 
and extent of absorption of the therapeutic ingredient (21 U.S.C. 
355(j)(8); 21 CFR 320.1(e)). BE studies are undertaken in support of 
ANDA submissions with the goal of demonstrating BE between a proposed 
generic drug product and its reference listed drug. The regulations 
governing BE are provided at 21 CFR in part 320.
    Previously, the Office of Generic Drugs (OGD) has provided 
information on how to design BE studies for specific products only when 
asked for assistance by individual applicants. In most cases, the 
requested information was not available anywhere else, and, in some 
cases, OGD performed its own research before responding to an 
applicant's request for information. In many cases, FDA responded to 
individual applicants in letter format after specific recommendations 
were prepared by individuals within the Center for Drug Evaluation and 
Research (CDER). With the increasing number of both ANDA submissions 
and requests for BE information during the last few years, this 
approach has become inefficient and extremely time consuming for the 
agency.
    As a result, after exploring various mechanisms that would allow us 
to conserve our resources while responding to the needs of industry and 
other interested persons, OGD has developed a new approach to making 
guidance available on product-specific BE studies. As before, BE 
recommendations will be developed by the agency based on its 
understanding of the characteristics of the listed drug, information 
derived from published literature, agency research, and consultations 
within different offices in CDER as needed based upon the novelty or 
complexity of the BE considerations. FDA proposes that, once drafted, 
product-specific BE recommendations will be made available through the 
process described in the guidance.

II. Procedures for Making BE Recommendations Available

    To streamline the process for making guidance available to the 
public on how to design product-specific BE studies, the agency intends 
to use the following process:
     Product-specific BE recommendations will be developed and 
posted on the CDER guidance page at https://www.fda.gov/cder/ 
in draft to facilitate public consideration and comment.
     The recommendations can be viewed by clicking on the URL 
associated with this guidance on the CDER guidance page (https://
www.fda.gov/cder/) or on the OGD page (see www.fda.gov/cder/
ogd/index.htm). Users can also search for a specific product BE 
recommendation using the search tool on the guidance page.
     Newly posted draft and final BE recommendations will be 
announced in the New/Revised/Withdrawn list, which is posted monthly on 
the CDER guidance page.
     The agency will issue a notice in the Federal Register 
announcing the availability on the FDA Web site of new product-specific 
draft and final BE recommendations. The notice will identify a comment 
period for the recommendations.
     Comments on product-specific BE recommendations will be 
considered in developing final BE recommendations.
     The BE recommendations will be revised as appropriate to 
ensure that the most up-to-date BE information is available to the 
public.
    FDA has decided to make the first group of BE recommendations 
available concurrently with the issuance of this draft guidance 
document. A notice of availability of the first group of draft product-
specific BE recommendations is also being published today. It includes 
a list of the drug products for which draft BE recommendations are 
available. Comments on the product-specific draft guidances are 
requested within 120 days.
    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 a new 
process for making available to sponsors FDA guidance on how to design 
product-specific bioequivalence studies to support 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.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/cder/guidance/index.htm or https://
www.fda.gov/ohrms/dockets/default.htm.


[[Page 30390]]


    Dated: May 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-10492 Filed 5-30-07; 8:45 am]
BILLING CODE 4160-01-S