FDA PreCheck Pilot Selects Eli Lilly, Regeneron

The U.S. Food and Drug Administration (FDA) has announced the selection of Eli Lilly (LLY) and Regeneron (REGN) for its PreCheck pilot program, designed to speed up the regulatory review of drug manufacturing facilities.

Program Details

The PreCheck program is an FDA pilot initiative that allows companies to submit their facilities for regulatory review during the construction phase, rather than waiting until completion. The FDA estimates this could save participating companies up to 14 months in review time.

Company Stance

Neither Eli Lilly nor Regeneron has issued an official statement regarding their participation. However, both companies are expected to benefit from accelerated manufacturing timelines for new drugs.

Regulatory Context

The program is part of the FDA's broader efforts to modernize its regulatory processes and expedite drug availability. The agency has shown increasing interest in innovative manufacturing approaches.

Potential Financial Impact

If successful, the program could reduce costs associated with manufacturing delays, enhancing the competitiveness of participating firms. However, the FDA has not disclosed selection criteria or the number of companies chosen.