Ditch The Paper: US FDA Encouraging Electronic Submission Of Promotional Materials During Pandemic
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.
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Technology modernization efforts, the expansion of cloud-based submission capabilities, and the ongoing COVID-19 pandemic could serve as catalysts to broaden FDA’s Real-Time Oncology Review program beyond cancer therapeutics, Pfizer exec Richard Jahn says.
Final guidance on regulatory pathway for antibacterial and antifungal drugs is not substantially different from 2018 draft version but gives more detail on the process for submitting promotional materials prior to dissemination and seeking termination of LPAD labeling limitations.
Accelerated Approval Program web page links to searchable databases for accelerated approvals of infectious disease products, vaccines, and other nonmalignant indications. New databases, which include products that converted to regular approval or were withdrawn, are modeled after Oncology Center of Excellence’s cancer drug databases that debuted in 2021.