Resources

Supply chain management is delicate — it only takes one "broken link" in the chain to significantly impact every aspect of a business's operations. In a time when a pandemic...

The European Commission’s formal pitch for revising the medicines legislative & EU regulatory framework was recently released. The new European regulatory documents targeting pharmaceutical industry reform & regulation law have...

The Food and Drug Administration (FDA) Commissioner, Dr. Robert Califf, recently testified in front of a Senate Appropriations subcommittee about core programs for the 2025 budget process. Executives at FDA...

As with many industries these days, pharmaceutical manufacturers are now reevaluating the structure of their manufacturing operations. A specific focus area is whether returning some or all production processes to...

Emergency Use Authorization (EUA) is a valuable asset that the FDA uses to make exceptions for unapproved medical devices during public health crises. It has brought up some controversy since...

The FDA recently updated guidance for clinical trials & trial design. This update stems from an objective of the 21st Century Cures Act (Cures Act). It includes recommendations for how...