About FDA

OPDP Form FDA-2253 submissions

Please be sure to use the most current version of Form FDA-2253 and carefully read the submission instructions:

Please consult the following draft guidance for information on submitting materials in electronic format (non-eCTD):

Please see draft guidance entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format - Promotional Labeling and Advertising Materials for Human Prescription Drugs for recommendations on how to submit.

Please note that implementation for the new eCTD M1 is still pending.  Please refer to the eCTD webpage for details and timing of implementation.

Page Last Updated: 04/21/2015
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