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Congress Explores Plans For Catching Up On US FDA Foreign Inspections

 
• By Bowman Cox

Absent agency said to have a plan to overcome vacancies and clear inspection backlog; subcommittee has other plans.

Capitol Building, Washington DC
GAO aims to give its assessment of FDA's plan by May.

The US Food and Drug Administration has a plan to overcome staffing challenges and catch up on backlogged foreign inspections in the wake of the COVID-19 pandemic, a congressional audit agency told a House Energy and Commerce subcommittee during a 6 February hearing on the agency’s foreign inspection program.

But no one from the FDA was there to talk about the plan; the oversight and investigations committee’s chair, Rep....

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• By Eliza Slawther

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EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 
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UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 
• By Neena Brizmohun

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

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More from Compliance

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

 
• By Eliza Slawther

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

 
• By Sue Sutter

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

 
• By Eliza Slawther

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