Outdated manufacturing technologies can lead to quality issues and recalls. But implementing the newest technologies isn’t easy either since there can be delays while reviewers familiarize themselves with the new technologies and determine whether or not they meet regulatory guidelines. Recognizing that the pharma industry is stuck between a rock and a hard place, the US FDA is looking to help smooth the introduction of new manufacturing methods with a new collaborative program.

In draft guidance titled “Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base Guidance for Industry,” the FDA explains that it is looking for companies to participate in a program where the FDA’s Emerging Technology Team (ETT) will work in partnership with pharmaceutical companies to assess and review submissions involving emerging technology (1).