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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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• By Dave Wallace

The latest incentive for firms to move manufacturing to the US is an FDA pilot program that will prioritize the review of US-manufactured and tested ANDA products.

Evita’s Mifepristone Approval Reignites Abortion Pill Controversy

 
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US FDA Gives Leucovorin Unprecedented Path To New Claim Amid ‘Autism Crisis’

 
• By Bridget Silverman

The Trump Administration's autism campaign convinced GSK to submit an sNDA for its no-longer-marketed leucovorin as a treatment for a rare folate deficiency condition with promises to ensure insurance coverage for autism.

Swissmedic Slashes Months Off Review Time For Certain Drug Filings

 
• By Anabel Costa-Ferreira

Switzerland’s health care products agency said it had cut the time it takes to review marketing applications for certain drugs submitted via its regulatory reliance procedure because it wants to further enhance the appeal of the pathway.

More from Conferences

EMA Unveils AI Tool That Improves Pharmacovigilance Signal Detection

 
• By Eliza Slawther

The European Medicines Agency is using artificial intelligence (AI) to screen scientific literature for safety signals and is also developing guidance for manufacturers on using AI in pharmacovigilance.

US FDA’s New ‘Plausible Mechanism Of Action’ Pathway Limited To Bespoke Therapies

 
• By Sue Sutter

Center for Biologics Evaluation and Research Director Vinay Prasad and Commissioner Martin Makary will introduce the new pathway soon in a New England Journal of Medicine article.

More To Be Done In Biopharma If Korea Is To Achieve Govt AI Vision

 
• By Jung Won Shin

Experts discussed challenges and requirements around adoption of AI and big data tools in South Korea's biopharma sector at a recent forum in Seoul, amid a broader push towards an AI-powered economy by the country's new government.