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FDA Aims For Transparency In Releasing New Risk-Based Site Selection Model For Determining Who Is Inspected Next

 
• By Joanne S. Eglovitch

US FDA explains new risk-based model for selecting manufacturing sites for inspection in US and abroad. By releasing information about the model, FDA aims to shed some transparency in its decision-making process. 

The US FDA’s Office of Pharmaceutical Quality on Sept. 5 issued new internal guidance that explains the risk factors agency staff must use to set GMP surveillance inspection priorities. By releasing information about the model, FDA aims to shed some transparency on its decision-making process.

The FDA Safety and Innovation Act (FDASIA) of 2012 amended section 510(h) of the Food, Drug and Cosmetic Act by replacing the fixed minimum inspection interval for domestic establishments with...

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US FDA’s Familiar Drug Pricing To-Do List

 
• By Michael McCaughan

President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.

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.

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

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

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• By Neena Brizmohun

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