Day: October 9, 2025

The FDA relies on Good Clinical Practice (GCP) inspections to evaluate regulatory compliance and verify data integrity, but unlike the US-based clinical sites, foreign GCP inspections are rare. A recent retrospective analysis provides a comprehensive look at the FDA’s GCP inspections conducted between fiscal years (FY) 2016 and 2018, shedding light on the agency’s operational … Read more

The FDA has launched its PreCheck program and a new ANDA Prioritization pilot, ostensibly to address supply chain vulnerability by promoting domestic pharmaceutical manufacturing. Driven by the narrative that the globalization of drug production compromises U.S. safety and security, these programs offer expedited reviews for new U.S. sites and generic drugs made entirely with domestic … Read more