Draft Guidance for Industry on Accelerated Approval Products: Submission of Promotional Materials; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Accelerated Approval Products: Submission of Promotional Materials.'' The accelerated approval regulations require that applicants, unless otherwise informed by the agency, submit to FDA for consideration during the preapproval review period copies of all promotional materials, including promotional labeling and advertisements, intended for dissemination or publication within 120 days following marketing approval. This draft guidance is intended to assist sponsors of drug and biological products who are submitting such materials as part of the accelerated approval process.