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GUIDANCE DOCUMENT

Residual Drug in Transdermal and Related Drug Delivery Systems Guidance for Industry August 2011

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2010-D-0246
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This 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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2010-D-0246.

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