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API Firms Advised to Gear Up for Inspections Under GDUFA and FMD

 
• By Joanne S. Eglovitch

Legislation mandating stricter rules on sourcing and inspecting active pharmaceutical ingredients will soon be implemented in the European Union and similar legislation will be introduced in the U.S. as part of the Generic Drug User Fee Act.

Under the EU's Falsified Medicines Directive, which is the EU's answer to fighting drug counterfeiting, pharmaceutical manufacturers will have to ensure that the APIs they source from countries outside the...

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US FDA’s Familiar Drug Pricing To-Do List

 
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US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
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Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

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

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

More from Compliance

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

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Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.