
FDA Releases Draft Guidance on Promotional Labeling and Advertising
The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.
FDA has released
Included in the guidance document are details on OPDP and APLB’s procedures for submitting promotional materials to fulfill postmarketing reporting requirements. The guidance also includes information on presubmission of promotional materials for accelerated approval products; promotional materials submitted pursuant to Section 503C of the FD&C Act; promotional materials submitted voluntarily for advisory comments; resubmissions; and more. The guidance addresses both paper and electronic submissions.
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