[Federal Register Volume 79, Number 94 (Thursday, May 15, 2014)]
[Notices]
[Pages 27874-27875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-11177]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0547]


Guidance for Industry on Abbreviated New Drug Applications: 
Stability Testing of Drug Substances and Products, Questions and 
Answers; 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 guidance for industry entitled ``ANDAs: Stability 
Testing of Drug Substances and Products, Questions and Answers.'' It 
replaces the draft guidance with the same name that published on August 
27, 2013 (78 FR 52931). This guidance clarifies stability testing 
recommendations discussed in International Conference on Harmonisation 
(ICH) stability guidances Q1A(R2) through Q1E for abbreviated new drug 
applications (ANDAs) and provides responses to public comments in a 
questions-and-answers format.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this 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 
guidance document.
    Submit electronic comments on the 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 (HFD-640),

[[Page 27875]]

Food and Drug Administration, 7500 Standish Pl., MPN2, Rm. 243, 
Rockville, MD 20855, 240-276-8546.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``ANDAs: Stability Testing of Drug Substances and Products, 
Questions and Answers.'' Because of increases in the number and 
complexity of ANDAs and FDA's desire to standardize generic drug 
review, on September 25, 2012 (77 FR 58999), FDA published a draft and 
on June 20, 2013 (78 FR 37231), published a final guidance entitled 
``ANDAs: Stability Testing of Drug Substances and Products'' 
recommending that the generic industry follow the approach to stability 
testing outlined in the ICH stability-related 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,'' May 
1997; (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. These guidances can be found 
on the FDA Guidances (Drugs) Web site under International Conference on 
Harmonisation--Quality at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065005.htm. FDA 
also recommended that industry follow the ICH outlined definitions, 
glossaries, references, and attachments.
    To more effectively address the public comments on the September 
2012 draft guidance on ``ANDAs: Stability Testing of Drug Substances 
and Products,'' we decided to publish a draft guidance in a questions-
and-answers format entitled ``ANDAs: Stability Testing of Drug 
Substances and Products, Questions and Answers.'' The draft of this 
guidance published on August 27, 2013 (78 FR 52931). We have carefully 
considered the comments we received on that draft, have updated the 
draft guidance as appropriate, and are now announcing the availability 
of the final guidance for industry entitled ``ANDAs: Stability Testing 
of Drug Substances and Products, Questions and Answers'' that 
supersedes the draft.
    This guidance discusses general issues, drug master files, drug 
product manufacturing and packaging, amendments to pending ANDA 
applications, and stability studies, with the intent of clarifying the 
stability testing data recommendations for ANDAs. In addition, the 
guidance addresses comments received on the August 2013 draft.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on stability testing of drug substances and 
products. 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. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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). The 
collections of information in 21 CFR parts 312 and 314 have been 
approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively.

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: May 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11177 Filed 5-14-14; 8:45 am]
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