[Federal Register Volume 78, Number 166 (Tuesday, August 27, 2013)]
[Notices]
[Pages 52931-52932]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20893]
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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Draft Guidance for Industry on Abbreviated New Drug Applications: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, 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availability of a draft guidance for industry entitled ``ANDAs:
Stability Testing of Drug Substances and Products, Questions and
Answers.'' This draft guidance clarifies stability testing
recommendations for abbreviated new drug applications (ANDAs) by
providing responses to public comments in a questions-and-answers
format. This draft guidance addresses public comments regarding FDA's
recommendation to generic drug manufacturers to follow International
Conference on Hamonisation (ICH) stability guidances Q1A (R2) through
Q1E.
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 28, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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 the 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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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,
Room 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Radhika Rajagopalan, Center for Drug
Evaluation and Research (HFD-640), Food and Drug Administration, 7500
Standish Pl., MPN2, Rm. 243, Rockville, MD 20855, 240-276-8546.
SUPPLEMENTARY INFORMATION:
[[Page 52932]]
I. Background
FDA is announcing the availability of a draft 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 recommending
the generic industry follow the approach 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,'' 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. 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.
While carefully considering the public comments on the September
2012 draft guidance, we decided to publish a draft guidance in a
questions-and-answers format. This draft guidance discusses stability
testing relating to general questions, drug master files, drug product
manufacturing and packaging, amendments to pending ANDA applications,
and stability studies.
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 ANDAs:
Stability Testing of Drug Substances and Products, Questions and
Answers. 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 draft 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: August 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20893 Filed 8-26-13; 8:45 am]
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