What is GDUFA? Understanding the Generic Drug User Fee Act
The pharm industry is a well-regulated sector, where innovation, safety, and accessibility have to be balanced. The Generic Drug User Fee Act (GDUFA) is one of the significant acts in the United States that can influence the process of reviewing and approving generic drugs.
Maintaining high standards for product safety and quality is a legal necessity for the food, pharmaceutical, cosmetic, and medical device industries. A good manufacturing practice audit, or GMP audit, is a comprehensive examination procedure intended to make sure that a business’s production procedures comply with global regulatory requirements.
Navigating Biosimilar Biologic Drug Submissions in Canada: A Strategic Guide
Biosimilars are transforming the contemporary pharmaceutical landscape as the need to find affordable treatment options increases. Health Canada has now issued a revised draft guidance to provide Information and Submission Requirements of Biosimilar Biologic Drugs (June 2025). This elaborated framework solidifies the dedication of Canada in regard to scientific precision, patient safety, and innovation.
EMA Launches Step 2 of eCTD v4.0 Technical Pilot for Centrally Authorised Products (CAP)
The European Medicines Agency (EMA) has officially launched Step 2 of the eCTD v4.0 Technical Pilot, focused on Centrally Authorised Products (CAP). This phase invites a limited number of Marketing Authorisation Holders (MAHs) to participate based on readiness and alignment with defined pilot scenarios.
An Analysis of GxP Audit Procedures and FDA Inspection Readiness Strategies
GxP audits are necessary in the pharmaceutical industry to ensure that operations comply with global regulatory standards, especially those established by the U.S. Understanding audit procedures and inspection readiness is essential for organizations involved in or supporting pharmaceutical manufacturing and R&D to ensure compliance and prevent costly enforcement actions.
