FDA PreCheck Raises the Stakes for Early Manufacturing

FDA PreCheck pushes pharmaceutical and biologics manufacturers to align manufacturing earlier, aiming to cut approval delays and strengthen US production resilience

18 Dec 2025

For years drugmakers treated manufacturing as an afterthought, something to tidy up once clinical success was assured. That habit is now being tested. Inside the Food and Drug Administration a quiet shift is underway, pushing production plans to the centre of regulatory strategy, and much earlier than many firms are used to.

The catalyst is the FDA’s PreCheck programme. Its premise is simple. Regulators want to see how and where medicines will be made well before approval looms. By peering into factories early, the agency hopes to prevent the last-minute manufacturing snags that delay launches and disrupt supply chains.

The message first landed among makers of biologics, vaccines and other therapies reliant on fermentation. Such processes are delicate. Small deviations can spoil whole batches. But PreCheck’s reach goes further. Across pharmaceuticals and biologics, the FDA is signalling that production design, facility layout and quality systems should mature alongside clinical development, not trail behind it.

PreCheck formalises that expectation in stages. In the initial phase companies discuss manufacturing readiness, from process controls to plant design. Later, as plans harden, the dialogue deepens. Regulators and firms build a shared view of what will be required when approval draws near.

For executives this amounts to a structural change. Manufacturing is no longer a box to tick at the end. Firms are being asked to show early that their production strategies can scale and remain consistent. In biologics, where contamination risks are ever present, early alignment can save months and avoid costly rework.

The market is responding. Contract development and manufacturing organisations, especially those with fermentation expertise, see clearer regulatory signals as a reason to invest in American capacity. When expectations are explicit, capital decisions become easier, even in unsettled economic times.

Not everyone is comfortable. Smaller biotech firms worry about being forced to commit too soon, when programmes are still fluid and funding fragile. Industry groups argue that early engagement should remain voluntary and flexible, lest it slow innovation.

Yet the prevailing mood is pragmatic. PreCheck is widely viewed as an evolution rather than an extra hurdle. By tying regulatory success more closely to production readiness, the FDA is nudging the industry towards sturdier manufacturing. Companies that adapt early may find the payoff is faster approvals, smoother scaling and a more resilient drug supply.