In the United States, the Orphan Drug Act (ODA) was passed in 1983 to facilitate the development of drugs or biologics that are used for the

On June 21, 2019, FDA released the Finalized Guidance for Promotional Labeling and Advertising Materials for Human Prescription Drugs. The Original draft guidance was published in April of 2015. Below are a few key takeaways on the immediate transition activities: https://www.fda.gov/media/128163/download With the finalization of this guidance, after 24 months, Ad Promo submissions that fall under Section 745A(a) of the FD&C Act are required, by law, to be submitted in eCTD f