1. Pink Sheet

Could Virtual Tools Help US FDA Eliminate Inspection Backlog?

 
• By Derrick Gingery

A former CDER compliance office director suggested the agency initiate virtual visits at low-risk facilities to help catch up on manufacturing facility surveillance inspections.

document review
Three to five RRAs, which involve document reviews, could be conducted in the same time as one inspection, Donald Ashley said. • Source: Shutterstock

Increasing virtual inspections may help the US Food and Drug Administration reduce its surveillance inspection backlog, but public health needs could complicate such a plan.

During the height of the COVID-19 pandemic, most international travel was restricted or not feasible, meaning many routine inspections of...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Compliance

More from Pink Sheet

US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited

 
• By Derrick Gingery

The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.

US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines

 
• By Sarah Karlin-Smith

US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.

Australia Targets Clinical Trial Reform, AI Use And Drug Shortages In 12-Month Plan

 
• By Eliza Slawther

Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.