FDA Updates Biosimilar Q&A Draft Guidance
FDA has released updated draft guidance on biosimilar development, clarifying how sponsors can use non-U.S.-licensed comparator products to support biosimilarity and what is required during FDA review.
International Equivalence: What Foreign Governments and Exporters Must Get Right to Access the U.S. Market
Accessing the U.S. market requires more than product compliance. Learn how the FSIS equivalence process works and where foreign inspection systems often fall short.
Why Food Recalls Are Increasing — And What Companies Must Do Differently
Food recalls are increasing despite stronger regulations and expanded food safety systems. In this Issue of the Month, EAS consultant Amandeep Dhillon examines the systemic causes behind this trend and what companies must do differently to reduce risk.
Building Food Safety Culture When No One Is Watching
What does food safety look like when no one is watching? In this Issue of the Month, EAS Independent Consultant Sebnem Karasu explores how real food safety culture is built, sustained, and revealed under pressure, and why systems, not slogans, make the difference.
Artificial Intelligence: Quality Friend or Foe
This Issue of the Month explores how artificial intelligence is being applied in regulated industries, examining potential benefits for quality and compliance programs while highlighting risks and considerations companies should evaluate before integrating AI into regulatory operations.