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

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Generics

Gateway To Africa: Natco Bids For 35.75% Of Adcock Ingram

 

Natco to buy out Adcock Ingram’s minority shareholders in what’s possibly its biggest M&A investment, opening up substantial opportunities in South Africa and the region. If the offer goes through, it will result in the delisting of Adcock, with Bidvest and Natco co-owning the firm.

The Generics Bulletin Top 50, Part One: German Giants Rise Up The Ranks

 
• By 

Two leading German generics and biosimilars giants were the big movers in our top ten ranking of off-patent industry leaders for 2025. We reveal the latest developments among the top players in the first instalment of this year’s Generics Bulletin Top 50.

Sun Strikes Further US Price-Fixing Settlement For $200m

 
• By 

The latest development in the long-running US generic price-fixing saga has seen Sun Pharma agree a $200m settlement in connection with an end purchaser action in Pennsylvania.

Just One Week To Go! Entry Deadline Looms For GGB Awards 2025

 
• By 

There is now just one week left to submit entries to the Global Generics & Biosimilars Awards 2025, with the entry deadline set for August 1.

More from Pink Sheet

No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

 
• By 

The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.

Base Benefit-Risk Decisions On Data, Not Opinion And Passion, CDER’s Tidmarsh Says

 
• By 

New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.

Pink Sheet Podcast: FDA’s New Top Drug Regulator, Sarepta’s Options After Elevidys Stand-Off

Pink Sheet reporter and editors discuss the potential impact George Tidmarsh could have as director of the US FDA Center for Drug Evaluation and Research and the issues threatening the future of Sarepta’s gene therapy Elevidys.