[Federal Register: July 9, 2007 (Volume 72, Number 130)]
[Notices]
[Page 37244-37245]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy07-76]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0524]
Guidance for Industry on ANDAs: Pharmaceutical Solid
Polymorphism; Chemistry, Manufacturing, and Controls Information;
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:
Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and
Controls Information.'' The guidance is intended to assist applicants
with the submission of abbreviated new drug applications (ANDAs) when a
drug substance exists in polymorphic forms.
DATES: Submit written or electronic comments on agency guidance
documents at any time.
ADDRESSES: Submit written requests for single copies of this 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 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 http://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Andre Raw, Center for Drug Evaluation
and Research (HFD-600), Food and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240-276-9310.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``ANDAs: Pharmaceutical Solid Polymorphism; Chemistry,
Manufacturing, and Controls
[[Page 37245]]
Information.'' This guidance provides: (1) A framework for making
regulatory decisions on drug substance sameness in terms of polymorphic
form and (2) decision trees which provide a recommended course to
monitor and control polymorphs in the drug substance and/or drug
product when the drug substance exists in relevant polymorphic forms.
On December 20, 2004 (69 FR 75987), the FDA announced the
availability of the draft version of this guidance. The public comment
period closed on March 21, 2005. A number of comments were received,
which the agency considered carefully as it finalized the guidance and
made appropriate changes. Most of the changes to the guidance were made
to clarify statements in the draft guidance.
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 pharmaceutical solid polymorphism. 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) 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default
.htm.
Dated: June 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-13171 Filed 7-6-07; 8:45 am]
BILLING CODE 4160-01-S