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In a two-page document released by the Office of Pharmaceutical Quality, FDA clarifies the reporting category for a postapproval change in the supplier of a hard gelatin capsule shell. The policy explains that when an applicant changes the supplier of a hard gelatin capsule shell, with no change in capsule composition or appearance, the information should be submitted in an annual report. However, changes in size, color or dye, or a change from gelatin to non-gelatin alternative, should be categorized as a prior approval supplement (PAS).
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
