FDA Announces New Steps to Streamline Biosimilar Development
FDA Announces New Steps to Streamline Biosimilar Development FDA Takes Additional Steps to Support Biosimilar Development The U.S. Food and Drug Administration has announced new actions aimed at streamlining the development of biosimilar medicines and improving access...
FDA Finalizes Rule Standardizing National Drug Code Format
FDA Finalizes Rule Standardizing National Drug Code Format FDA Final Rule Revises National Drug Code Format and Barcode Requirements FDA has issued a final rule revising the format of the National Drug Code (NDC) and updating certain drug label barcode requirements....
FDA Issues Guidance on Responding to Form 483 Observations Following Drug CGMP Inspections
FDA Issues Guidance on Responding to Form 483 Observations Following Drug CGMP Inspections FDA Releases Guidance on Responding to Form 483 Observations The U.S. Food and Drug Administration has issued a guidance document titled “Responding to FDA Form 483 Observations...
FDA Announces Public Meeting on Dietary Supplement Innovation and Ingredient Scope
FDA Announces Public Meeting on Dietary Supplement Innovation and Ingredient Scope FDA to Hold Public Meeting on Dietary Supplement Innovation and Ingredient Scope The U.S. Food and Drug Administration has announced an upcoming public meeting focused on dietary...
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.