[Federal Register Volume 75, Number 148 (Tuesday, August 3, 2010)]
[Notices]
[Pages 45640-45641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19041]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0246]
Draft Guidance for Industry on Residual Drug in Transdermal and
Related Drug Delivery Systems; 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availability of a draft guidance for industry entitled ``Residual Drug
in Transdermal and Related Drug Delivery Systems.'' This draft guidance
provides recommendations to developers and manufacturers of transdermal
drug delivery systems (TDDS), transmucosal drug delivery systems
(TMDS), and topical patch products regarding use of an appropriate
scientific approach during product design and development--as well as
during manufacturing and product lifecycle management--to ensure that
the amount of residual drug substance at the end of the labeled use
period is minimized. The draft guidance is applicable to
investigational new drug applications (INDs), new drug applications
(NDAs), abbreviated new drug applications (ANDAs), and supplemental new
drug applications (sNDAs) for TDDS, TMDS, and topical patch products.
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance, including comments regarding the proposed collection of
information, by November 1, 2010.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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 that 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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Terrance Ocheltree, Center for Drug
Evaluation and Research, Food and Drug Administration, Bldg. 21, rm.
1609, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-
1988.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Residual Drug in Transdermal and Related Drug Delivery
Systems.'' This draft guidance provides recommendations to developers
and manufacturers of TDDS, TMDS, and topical patch products regarding
use of an appropriate scientific approach during product design and
development--as well as during manufacturing and product lifecycle
management--to ensure that the amount of residual drug substance at the
end of the labeled use period is minimized.
Existing TDDS, TMDS, and topical patches contain a larger amount of
the drug substance than what is intended to be delivered to the
patient. This excess amount of drug substance is needed to facilitate
delivery of the intended amount of the drug to the patient and remains
as residual drug in the used system. The amount of residual drug
substance in TDDS, TMDS, and topical patches has a significant
potential to impact the products' quality, safety, and efficacy.
Consequently, it is necessary to ensure that an appropriate scientific
approach is used to design and develop these products. The approach
should ensure that the amount of residual drug substance is minimized
consistent with the current state of technology.
Currently marketed TDDS, TMDS, and topical patches may retain 10 to
95 percent of the initial total amount of drug after the intended use
period. This raises a potential safety issue not only to the patient,
but also to others including family members, caregivers, children, and
pets. For example, adverse events due to a patient's failure to remove
TDDS at the end of the intended use period have been reported and are
generally related to an increased or prolonged pharmacological effect
of the drug. Some children have died from inadvertent exposure to
discarded TDDS. Reported adverse events resulting from various quality
problems pertaining to TDDS have lead to product recalls, withdrawals,
and public health advisories.
To reduce some of these risks, we recommend that an enhanced design
and development approach--specifically Quality by Design (QbD), as
described in the International Conference on Harmonization (ICH)
guidance for industry Q8(R2) Pharmaceutical Development--be used when
developing and manufacturing TDDS, TMDS, and topical patches. We also
recommend that sufficient scientific justification to support the
amount of residual drug in TDDS, TMDS, or topical patches be included
in an application. The level of information in the justification should
be sufficient to demonstrate product and process understanding and
ensure that a scientific, risk-based approach has been taken to
minimize the amount of residual drug in a system after use to the
lowest possible level. Furthermore, it is expected that the amount of
residual drug in a newly developed system will not exceed that of
similar FDA-approved products.
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 residual
drug in transdermal and related drug delivery systems. It does not
create or confer any rights for or on
[[Page 45641]]
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. 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).
Information in an application on the product and process development
and justification for the final formulation and system design is
approved by OMB under control numbers 0910-0001 and 0910-0014.
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: July 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19041 Filed 8-2-10; 8:45 am]
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