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

A QMSR State of Mind: FDA Adopts New Inspection Approach for Medical Devices as Quality Management System Regulation Takes Effect

On February 2, 2026, FDA’s new Quality Management System Regulation (“QMSR”) for medical devices became effective, two years after FDA’s issuance of a final rule to implement the QMSR. The QMSR ...
JD Supra

New Draft Guidance Addresses FDA’s Records Access Authority for Cosmetics Under MoCRA

On January 21, the US Food and Drug Administration (FDA) issued a draft guidance clarifying the agency’s authority to access and copy records related to cosmetic products under the Modernization of ...
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 ...
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In today's Pharmaceutical Executive Daily, the FDA issues new draft guidance aimed at reducing the cost and complexity of ...
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, ...
Yahoo

FDA Considers Scaling Back Inspections, Raising Questions About Food Safety

The FDA is considering reducing its routine food safety inspections and shifting more responsibility to state agencies. However, critics are concerned that this action could undermine oversight and ...