Resources

The U.S. Food and Drug Administration (FDA) recently published multiple new guidance documents to help accelerate supply chain security and new product tracing requirements in the pharmaceutical industry. While most...

The US Food and Drug Administration (FDA) is likely going to continue to use remote inspection alternatives in a "hybrid approach" with in-person inspections, supplemented by audit and FDA inspection...

The USA Food and Drug Administration (FDA) recently provided updated regulatory guidance for Product Lifecycle Management in the pharmaceutical industry. The guidance helps pharmaceutical companies and manufacturers better understand the...

The Food and Drug Administration (FDA) recently announced a new guidance program for the life science industry regarding data integrity. This FDA guidance draft is currently open & available for...

The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) have recently identified 10 guiding principles for the development of...

The US Food and Drug Administration (FDA) recently issued final guidance for Biologics industry executives to help define modifications to existing products and update submission procedures. The primary focus of...