The US Food and Drug Administration (FDA) has launched a new excipient pilot program for candidates for finding out ways to formulate new products. The leading players of the pharmaceutical industry has openly supported FDA’s excipient program.
FDA says, the program will uncover new pathways for manufacturers for formulating new products. The FDA program will allow the FDA to review the inactive ingredients put forward by the manufacturers prior to their use in the new drug formulations.The excipients are inactive ingredients used during the formulation of drugs but are crucial or play an important role in producing the product. And the novel excipient is an inactive ingredient that is not used in the formulation of approved drug products. The drug manufacturers may be reluctant to use the novel excipients as it may be further disapproved by the FDA.
The excipient program aims to foster development of excipients wherein the manufacturers or drug developers may have found difficulties in using the excipients.The pilot program is also aimed at reviewing the novel excipients and accepting new proposals of the manufacturers and drugmakers.
The excipient manufacturers whose proposals are accepted by the FDA will be further asked to submit toxicology package and other documents.If the excipients are approved by the FDA the same will get the recognition by FDA without trying these investments for risks or without any specific filing by the excipient manufacturer. FDA says, the program will uncover new pathways for manufacturers for formulating new products.