eHandbook: Regulatory Compliance

Despite significant budget and headcount reductions at the U.S Food and Drug Administration (FDA), the agency has recently unveiled several initiatives meant to streamline regulations and support transparency, while boosting its enforcement activities.

The FDA’s PreCheck program is designed to support construction of domestic pharmaceutical manufacturing facilities and reduce dependence on foreign drug production. However, uncertainty remains as the agency looks to launch its pilot phase.

The FDA also announced a one-day inspectional assessment pilot to complement its standard inspections. The pilot is being conducted across multiple agency inspectorates including biologics, clinical research programs, and medical products.

While the FDA is pursuing a flexible approach to chemistry, manufacturing, and controls (CMC) requirements for cell and gene therapies, the agency’s efforts to remove CMC barriers are not being translated to individualized therapies for genetic conditions.

At the same time, regulatory modernization is needed for cell therapies to accommodate risk-based manufacturing paradigms, automation and robotics, advanced analytics and AI, as well as integrated digital systems. And, as regulatory support grows for botanical therapies, developers face the complexity of standardizing nature for pharma production.