FDA releases new draft guidance in April 2015 entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format-Promotional Labeling and Advertising Materials for Human Prescription Drug. The purpose of this guidance is to make it easier for marketing professionals in the pharmaceutical industry to submit their advertisements and promotional materials for review and approval. Traditionally, FDA’s Office of Prescription Drug Promotion (OPDP) required pharmaceutical companies to submit their materials using a paper-based for known as the Form FDA 2253. As these companies are increasingly using electronic media such as websites, emails, social media, etc. to promote a drug, OPDP is proposing the idea of using its electronic common technical document (eCTD) format instead. Two years following the finalized document, all companies will be required to submit their advertisements and promotional materials using OPDP’s electronic form.
If you would like to submit comments to FDA regarding this draft guidance, be sure to submit here by July 21, 2015.
Click here to read FDA guidance document. For additional information, read Alexander Gaffney’s article on RAPS.org.