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Non-Compendial Product Quality Screening Draws US FDA’s Criticism

 
• By Bowman Cox

Third-party screening of US-marketed drug products is worse than pointless if done with subpar test methods, agency tells PDA/FDA meeting. Meanwhile, release-testing with such methods has been triggering warning letters.

Dissolution testing apparatus
fda: dissolution should be tested the usp way or something like it • Source: Shutterstock

US Food and Drug Administration officials recently criticized independent third parties and drug product manufacturers for not using US Pharmacopeia compendial or comparable methods when testing drug product quality.

Speaking at the 18-20 September Parenteral Drug Association/FDA conference, they outlined why they believe organizations should not rely on such...

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China’s Qilu Looks To US Hospitals Market With Sagent Injectables Collaboration

 
• By Dean Rudge

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Who’s Hired? Stada Picks Biogen’s Biosimilars Chief Henshaw To Lead Specialty Segment

 
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Snapshot Of India’s Pharma Manufacturing Network Amid ‘Trumponomics’

 
• By Anju Ghangurde

Collating data on the global manufacturing network of leading Indian drug makers, the markets serviced and production hubs for active pharmaceutical ingredients. Will ongoing geopolitical tensions and policy shifts have a bearing on some of these down the line?

Alchem Fined Over Buscopan API Cartel

 
• By Dave Wallace

After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.

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HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By Sue Sutter

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

EU Health Chief Declares There Is No Better Alternative Than TEVs to Spark Antibiotic Innovation

 
• By Francesca Bruce

Clarity on what transferable exclusivity vouchers may look like for new antimicrobial drugs could be nearing. Denmark’s new presidency of the Council of the EU has prioritized concluding its negotiations with European Parliament over the legislative overhaul of the EU’s pharmaceutical legislation.

EU Fines Alchem Over Buscopan API Cartel

 
• By Dave Wallace

After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.