Regulatory Alerts2013-11-13 | C1-2013-26790Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
The Food and Drug Administration proposes to amend its regulations to revise and clarify procedures for application holders to change product labeling to reflect newly acquired information prior to FDA review. The rule creates parity among holders by permitting generic drug applicants to distribute revised labeling that temporarily differs from the reference listed drug upon submission of a changes being effected supplement. It also clarifies public availability processes for labeling supplements and allows such supplements for specific changes to physician labeling information formats.
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