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GUIDANCE DOCUMENT

Size of Beads in Drug Products Labeled for Sprinkle Rev.1 Guidance for Industry May 2012

Download the Final Guidance Document
Final
Docket Number:
FDA-2011-D-0021
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides applicants preparing or submitting new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics licensing applications (BLAs) the Center for Drug Evaluation and Research’s current thinking on appropriate size ranges for beads in drug products that are labeled to be administered via sprinkling (e.g., capsules or packets containing beads).

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Submit Comments Online

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-2011-D-0021.

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