Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this month.

New drug, biologic FDA fillings will only be done electronically

Is print dead? Maybe, if you are looking to file something with the FDA.

The FDA will require all new drug and biologic product submissions to be filed electronically within the next two years, reported the Regulatory Affairs Professionals Society.

In 2003, the FDA adopted the International Conference on Harmonisation's electronic common technical document, better known as eCTD. It has been accepting electronic applications since the, but now, it will be the only way to do it.

By doing this, it makes it easier for a company to submit an application to multiple regulation agencies, because the eCTD is used across the world, according to the report.

Pharmaceutical Innovations Report
Discover the latest breakthrough packaging technologies shaping the pharmaceutical sector. This report dives into cutting-edge innovations, from smart containers that enhance patient safety to eco-friendly materials poised to transform the industry’s sustainability practices. All from PACK EXPO. Learn how forward-thinking strategies are driving efficiency and redefining what’s possible in pharma packaging.
Learn More
Pharmaceutical Innovations Report
List: Digitalization Companies From PACK EXPO
Looking for CPG-focused digital transformation solutions? Download our editor-curated list from PACK EXPO featuring top companies offering warehouse management, ERP, digital twin, and MES software with supply chain visibility and analytics capabilities—all tailored specifically for CPG operations.
Download Now
List: Digitalization Companies From PACK EXPO