[Federal Register Volume 75, Number 228 (Monday, November 29, 2010)]
[Notices]
[Pages 73108-73109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29896]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0584]
Guidance for Industry on Abbreviated New Drug Applications:
Impurities in Drug 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 guidance for industry entitled ``ANDAs: Impurities in
Drug Products.'' This guidance updates recommendations regarding
degradation products and updates the draft guidance ``ANDAs: Impurities
in Drug Products'' announced in December 1998 in conformance with the
revision of the International Conference on Harmonisation (ICH)
guidance for industry ``Q3B(R) Impurities in New Drug Products,'' which
was announced in August 2006.
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
[[Page 73109]]
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: Devinder Gill, Center for Drug
Evaluation and Research (HFD-630), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8483.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``ANDAs: Impurities in Drug Products.'' In December 1998, FDA
issued the draft guidance ``ANDAs: Impurities in Drug Products,'' and
in August 2005, FDA revised it in conformance with the ``Q3B(R)
Impurities in New Drug Products'' guidance for industry that was
announced in August 2006.
We are issuing the final guidance to: (1) Update information on
listing of degradation products, setting acceptance criteria, and
qualifying degradation products (thresholds and procedures) in
abbreviated new drug applications (ANDAs) in conformance with the
revision of the guidance for industry on Q3B(R) and (2) remove those
sections of the 1998 draft guidance containing recommendations that are
no longer needed because they are addressed in the more recent Q3B(R).
The Q3B(R) was developed by the ICH to provide guidance on impurities
in drug products for new drug applications (NDAs). However, the Agency
believes that many of the recommendations provided on impurities in
NDAs also apply to ANDAs.
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 impurities in drug products submitted as
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. It is no
longer necessary to send two copies of mailed 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.
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: November 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29896 Filed 11-26-10; 8:45 am]
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