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Unannounced Foreign Drug Inspection Pilot, Other US Inspection Measures Enacted

 
• By Bowman Cox

A suite of pharmaceutical inspection measures stripped from the user fee renewal legislation were added to the US FY 2023 spending law, including provisions for new inspection priorities, remote alternatives, mutual reliance, internal FDA coordination and unannounced foreign inspections.

Inspector
surprise! new inspection provisions take effect. • Source: Shutterstock

US Food and Drug Administration drug manufacturing inspection reforms stripped from user fee legislation reappeared in the fiscal year 2023 appropriations bill that President Biden signed into law 29 December.

The user fee bill was enacted 30 September (Also see "US FDA Begins Implementing New User Fee Programs, But What About The Actual Fees?" - Pink Sheet, 4 October, 2022.) after shaking off riders like the inspection provisions that had bowed it like a snow-slumped evergreen

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US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
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More from Compliance

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

Aragen’s CEO Says NIH Funding Cut Means Less R&D Money, And Tariffs Would Add To Woes

 
• By Vibha Ravi

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US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel

 
• By Sue Sutter and Derrick Gingery

Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate, and two other senior inspection officials are departing, along with Mark Raza, chief counsel from 2021 until January.