Pharma companies push FDA for risk-based flexibility in container-closure testing guidance

Major pharma firms have written to the FDA urging a shift in its current guidance on testing container-closure systems for drug and biologic products.

They argue that a risk-based, flexible approach would be appropriate when manufacturers use well-established materials and technologies, reducing unnecessary testing burdens.

The companies contend that such a framework would maintain product safety while streamlining development and manufacturing processes.