Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Size of Beads in Drug Products Labeled for Sprinkle." 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 (CDER'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). In the Federal Register of January 19, 2011 (76 FR 3144), FDA announced the availability of the draft version of this guidance. The public comment period closed on April 19, 2011. A number of comments were received from the public, all of which the Agency considered carefully as it finalized the guidance and made appropriate changes.