USA – FDA launches excipient pilot program

The US Food and Drug Administration (FDA) has launched a new pilot program to review novel excipients for use in meeting unmet needs in formulating new drug products. The pilot has the full support of the pharmaceutical industry.

FDA called the program “a new pathway for manufacturers to obtain FDA review of certain novel excipients (inactive ingredients) prior to their use in drug formulations,” according to a 7 September announcement.

Excipients are inactive ingredients reviewed as a component of a finished drug product in a new drug application or a generic application, whereas a novel excipient is an inactive ingredient that has not been previously used in an approved drug product. Drug manufacturers may be reluctant to use novel excipients because it is unclear that FDA would accept the available safety information on the material and approve its use in a drug product…