[Federal Register Volume 62, Number 193 (Monday, October 6, 1997)]
[Notices]
[Pages 52138-52139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26412]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0410]
Guidance for Industry on SUPAC-MR, Modified Release Solid Oral
Dosage Forms; Scale-Up and Postapproval Changes for Chemistry,
Manufacturing, and Controls; 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 ``SUPAC-MR: Modified
Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes:
Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing
and In Vivo Bioequivalence Documentation.'' The purpose of this
guidance document is to provide insight and recommendations to
pharmaceutical sponsors of new drug applications (NDA's), abbreviated
new drug applications (ANDA's), and abbreviated antibiotic applications
(AADA's) who intend to change the components or composition, the
manufacturing (process or equipment), the scale-up/scale-down of
manufacture, and/or the site of manufacture of a modified release solid
oral formulation during the postapproval period. This guidance document
represents the agency's current thinking on scale-up and postapproval
changes (SUPAC) for modified release solid oral dosage forms regulated
by the Center for Drug Evaluation and Research (CDER).
DATES: Written comments may be submitted at any time.
ADDRESSES: Submit written requests for single copies of ``SUPAC-MR:
Modified Release Solid Oral Dosage Forms; Scale-Up and Postapproval
Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution
Testing and In Vivo Bioequivalence Documentation'' to the Drug
Information Branch (HFD-210), Center for Drug Evaluation and Research,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Send two self-addressed adhesive labels to assist that office in
processing your requests. Submit written comments on the guidance
document to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Mehul U. Mehta, Center for Drug
Evaluation and Research (HFD-860), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-0501.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
guidance for industry entitled ``SUPAC-MR: Modified Release Solid Oral
Dosage Forms; Scale-Up and Postapproval Changes: Chemistry,
Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo
Bioequivalence Documentation.'' The purpose of this guidance document
is to provide insight and recommendations to pharmaceutical sponsors of
NDA's, ANDA's, and AADA's who intend to change: (1) The components or
composition; (2) the manufacturing (process or equipment); (3) the
scale-up/scale-down of manufacture; and/or (4) the site of manufacture
of a modified release solid oral formulation during the postapproval
period. The guidance document defines the following: (1) Levels of
change; (2) recommended chemistry, manufacturing, and controls (CMC)
tests to support each level of change; (3) recommended in vitro
dissolution release tests and/or in vivo bioequivalence tests to
support each level of change; and (4) documentation to support the
change.
For postapproval changes for modified release dosage forms that
affect components and composition, manufacturing process or equipment
changes, scale-up, and site change, this guidance supersedes the
recommendations in section 4.G of the Office of Generic Drugs Policy
and Procedure Guide 22-90 (FDA, September 11, 1990). For all other
dosage forms and changes, this guidance does not affect the
recommendations in Guide 22-90.
This guidance document represents the agency's current thinking on
SUPAC for modified release solid oral dosage forms regulated by CDER.
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
statute, regulations, or both.
Interested persons may, at any time, submit written comments on the
guidance document to the Dockets Management Branch (address above). Two
copies of any comments are to be submitted, except that individuals may
submit one copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. A copy of the
guidance
[[Page 52139]]
document and received comments may be seen in the office above between
9 a.m. and 4 p.m., Monday through Friday.
An electronic version of this guidance is also available on the
Internet at http://www.fda.gov/cder/guidance/index.htm.
Dated: September 29, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-26412 Filed 10-3-97; 8:45 am]
BILLING CODE 4160-01-F
