Drugs

FDA Issues Emerging Tech Application Guidance

FDA is publishing a guidance, Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization, with recommendations for drug companies interested in participating in a program involving submission of emerging manufacturing technology. The document finalizes a guidance issued 12/23/15.

The agency says the program is open to companies that intend to include the technology as part of a regulatory submission including an IND, original or supplemental NDA, ANDA, or BLA, or application-associated drug master files reviewed by CDER, and where that technology meets other criteria described in the guidance.

“FDA is committed to supporting and enabling pharmaceutical innovation and modernization as part of the agency’s mission to protect and promote the public health,” the guidance says. “While the implementation of emerging technology is critical to advancing product design, modernizing pharmaceutical manufacturing, and improving quality, FDA also recognizes that the adoption of innovative approaches may represent challenges to industry and the agency. Issues in pharmaceutical manufacturing have the potential to significantly impact patient care as failures in quality may result in product recalls and harm to patients. Additionally, product failures or facility, equipment, or manufacturing problems are a major factor leading to disruptions in drug supply.”

Under the program, FDA says, drug companies can, before the regulatory submission, submit questions and proposals about the use of specific emerging technology to a group within the FDA Emerging Technology Team, which includes relevant representation from all agency pharmaceutical quality functions. The guidance says the team works in partnership with relevant pharmaceutical quality offices and assumes a leadership or co-leadership role for the cross-functional quality assessment team for submissions involving emerging technology.

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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