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The Quality Lowdown: ICH Q13 and Q14, Gene Therapy CMC, Drug Shortage Gaps, And An Excipient Misstep

 
• By Bowman Cox

ICH launches continuous manufacturing and analytical procedure guidelines while US FDA promises advice on gene therapy CMC, battles drug shortages and sees what went wrong with certain eye injections.

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Last week heralded two advances in global drug quality, with the International Council on Harmonization announcing plans for guidance on continuous manufacturing and analytical procedure development, while the US FDA’s center for biologics is promising more details on how firms should explain how they intend to manufacture gene therapies.

Meanwhile, FDA provided new insight into the lengths it has taken to narrow the gap on drug shortages – and...

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US FDA’s Familiar Drug Pricing To-Do List

 
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More from Compliance

Novo, Lilly Ad Challenges Cause Discontinued Claims For Compounded GLP-1s

 
• By Sue Sutter

Two pharmacies, a medical spa and a telehealth company voluntarily removed efficacy, safety and quality claims for compounded GLP-1 products after innovator companies filed challenges with the National Advertising Division.

EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 
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How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
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