CDER wants sponsors to use the NextGen Portal for electronic submission of promotional pieces to the Office of Prescription Drug Promotion, rather than sending in paper or physical media such as CDs; availability of this alternative pathway does not affect requirement for eCTD submission of some types of promotional materials starting in June 2021.

US FDA research finds consumer attitudes are more positive when animated characters personify drug benefits or sufferers, rather than representing the disease itself; OPDP staff also present research on consumer understanding of oncology endpoints and prescribers’ ability to detect deceptive ads.

As generalist investors continue to push higher the stock prices of biotech companies that announce the most tenuous of coronavirus developments, the track record of biotech companies developing even vaccines for which the antigen is proven to be safe and efficacious remains poor.