BioSpace

AbbVie, Amgen, Lilly Lead Calls for FDA To Update Post-Approval Change Rules

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...
FiercePharma

In addressing inspection shortfall, FDA says it's gaining more inspectors than it's losing

In its effort to play catch up after thousands of factory inspections were delayed during the coronavirus pandemic, the FDA is still lagging woefully behind and is unable to approach its pre-COVID ...
Fast Company

FDA drug-plant inspections still haven’t recovered from the pandemic, AP reports

As COVID-19 swept across the globe in early 2020, the Food and Drug Administration (FDA) pulled most of its safety inspectors from the field, creating a massive backlog of uninspected pharmaceutical ...
JD Supra

FDA Drug Inspections Post–Workforce Reductions: Potential Implications and Practical Steps Forward

The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time ...
JD Supra

FDA to Expand Unannounced Inspections of Foreign Facilities — Manufacturers, Research Firms Should Prepare

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines ...
NPR

How FDA cuts could make the food and drug supply less safe

When Health and Human Services Secretary Robert F. Kennedy Jr. announced in March that he would eliminate thousands of jobs from federal health agencies, he promised that he would spare the inspectors ...
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, ...