How The US FDA Honed Remote Tools To Assess Facilities During COVID Inspection Hiatus

FDA officials outline the impact of using alternative tools to assess manufacturing facilities amid COVID-19 and share key experiences around these, including with remote interactive evaluations.

FDA office
Alternative Tools Seen As Crucial To Manage Inspection Backlog • Source: Alamy

Remote alternatives to inspections played a key role in the US Food and Drug Administration's efforts to assess drug manufacturing facilities during the pandemic as participants gained experience with them, according to agency and industry officials who reflected on their learnings at a recent conference.

As COVID-19-related travel restrictions led to increased reliance on inspection alternatives, participants found ways to enhance them by, for example,...

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

More from Manufacturing

More from Compliance

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

Novo, Lilly Ad Challenges Cause Discontinued Claims For Compounded GLP-1s

 
• By 

Two pharmacies, a medical spa and a telehealth company voluntarily removed efficacy, safety and quality claims for compounded GLP-1 products after innovator companies filed challenges with the National Advertising Division.

EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 

The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.