Drugmakers Call for Expanded Novel Excipient Review Pilot

In comments to the FDA, multiple drugmakers urged the agency to expand the scope of its planned pilot for reviewing novel excipients outside of drug applications.

The FDA is proposing to review a limited number of novel excipient submissions per year outside of an IND, NDA or BLA, something it hasn’t done before.

AstraZeneca suggested that the agency widen the scope of the pilot program beyond “excipients that do not have a well-established history of safe use in food” to include those taken by new routes of administration.