[Federal Register Volume 77, Number 186 (Tuesday, September 25, 2012)]
[Notices]
[Pages 58999-59000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23543]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0938]


Draft Guidance for Industry on Abbreviated New Drug Applications: 
Stability Testing of Drug Substances and Products; 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availability of a draft guidance for industry entitled ``ANDAs: 
Stability Testing of Drug Substances and Products.'' FDA is 
recommending that generic drug manufacturers follow the stability 
testing recommendations in the International Conference on 
Harmonisation (ICH) guidances Q1A(R2) through Q1E. The use of these ICH 
recommendations will standardize FDA's stability testing policies, 
which will help make the abbreviated new

[[Page 59000]]

drug application (ANDA) review process more efficient.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by December 24, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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

FOR FURTHER INFORMATION CONTACT:  Radhika Rajagopalan, Center for Drug 
Evaluation and Research, Food and Drug Administration, 7500 Standish 
Pl., MPN2, Rm. 243, HFD-640, Rockville, MD 20855, 240-276-8546.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``ANDAs: Stability Testing of Drug Substances and Products.'' 
Because of increases in numbers of ANDAs and their complexity, the FDA 
is considering standardizing stability testing policies by adopting 
recommendations in the following stability related ICH guidances: (1) 
``Q1A (R2) Stability Testing of New Drug Substances and Products,'' 
November 2003; (2) ``Q1B Photostability Testing of New Drug Substances 
and Products,'' November 1996; (3) ``Q1C Stability Testing for New 
Dosage Forms,'' November 1996; (4) ``Q1D Bracketing and Matrixing 
Designs for Stability Testing of New Drug Substances and Products,'' 
January 2003; and (5) ``Q1E Evaluation of Stability Data,'' June 2004. 
FDA is also considering adopting the ICH outlined definitions, 
glossaries, references, and attachments.
    Although the ICH stability guidances were developed for new drug 
applications to ensure the stability of new drug substances and 
products, FDA believes the recommendations provided in the ICH 
guidances on stability testing are appropriate for ANDAs as well. This 
guidance contains FDA's recommendation that ANDAs submitted pursuant to 
section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)), and the drug master files that support ANDAs, follow the 
stability recommendations provided in the ICH stability guidances.
    This guidance also replaces stability study storage condition 
recommendations made in an August 18, 1995, letter that the Center for 
Drug Evaluation and Research's (CDER's) Office of Generic Drugs (OGD) 
sent to all ANDA applicants, which is available on CDER's Web site: 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064995.htm. The letter stated that OGD would accept ANDAs 
with the ICH recommended long term room temperature conditions for 
stability studies, 25  2[deg]C, 60  5 percent 
RH.
    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 stability 
testing of drug substances and products for 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 to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. 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. 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: September 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-23543 Filed 9-24-12; 8:45 am]
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