USA – FDA official breaks down novel excipient pilot program

A new pilot program from the US Food and Drug Administration (FDA) dedicated to reviewing quality and toxicology data for novel drug excipients is aimed at speeding drug development by providing an easier pathway for the agency to qualify these ingredients.

“In some cases, FDA may find issues with the excipients used in a drug development application, which can affect and even delay the application,” explained FDA official Karen Davis Bruno, associate director of pharmacology/toxicology in the Office of New Drugs at the Center for Drug Evaluation and Research (CDER).

Although a new excipient might offer advantages such as better drug bioavailability, enhanced absorption, or the potential for a more abuse-deterrent formulation for opioids, for example, the development process can be slowed when FDA does not have full safety data for the novel material. The novel excipient review pilot program “aims to address this problem head-on,” said Davis Bruno, speaking in a recent interview published on FDA’s website…