FDA Foreign Inspection Gap Grows as U.S. Drug Imports Surge, New Study Finds

Foreign facilities failed FDA GMP inspections at up to 1.8x the U.S. rate. Journal of Pharmaceutical Innovation study ...
JD Supra

FDA Issues Guidance on Alternative Tools for Assessing Drug Manufacturing Facilities in Pending Applications

On September 12, the US Food and Drug Administration (FDA) released guidance detailing its approach to using alternative tools, such as remote regulatory assessments (RRAs), information sharing with ...
PharmExec

Pharmaceutical Executive Daily: FDA's New Guidance for Biosimilar Development

In today's Pharmaceutical Executive Daily, the FDA issues new draft guidance aimed at reducing the cost and complexity of biosimilar development, Novo Nordisk responds to an FDA warning letter ...
PharmiWeb

The Critical Role of Audits in Ensuring Compliance: A Comprehensive Guide

Introduction to AuditsIn the fields of pharmaceuticals and medical devices where regulation is imposed, compliance with the quality standards set by the authorities is vital for the protection of the ...
Agri-Pulse

Shifting FDA food safety inspection to states has big challenges

After years of discussion, the Food and Drug Administration may shift responsibility for routine food safety inspection to the states. While industry and food safety experts say it's a logical move, ...