Drugs

Guidance on Advancing Emerging Drug Making Technologies

FDA has releases a draft guidance on “Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base” that provides recommendations to pharmaceutical companies interested in participating in a program involving chemistry, manufacturing, and controls (CMC) submissions containing emerging manufacturing technology. “Modernizing manufacturing technology may lead to a more robust manufacturing process with fewer interruptions in production, fewer product failures (before or after distribution), and greater assurance that the drug products manufactured in any given period of time will provide the expected clinical performance,” the document says. “For example, contemporary aseptic manufacturing facilities that are highly automated and use isolators and other modern separation technologies have the potential to decrease the risk of contamination from the processing line.”

Under the program, pharmaceutical companies can submit pre-submission questions and proposals about the use of a specific emerging technology to CDER’s Emerging Technology Team (ETT). “The ETT will work in partnership with relevant pharmaceutical quality offices and assume a leadership or co-leadership role for the cross-functional quality assessment team (including review and on-site agency evaluation) for submissions involving emerging technology,” the document says.

FDA notes that pharmaceutical companies may have concerns that using such technologies could result in delays while agency reviewers become familiar with them and determine how they fit within existing regulatory approaches. Through the ETT, CDER intends to leverage existing resources within the agency to facilitate the regulatory review of such submissions, it says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome