Featured Pharma Online Editorial
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How Recce Is Delivering 5,000 Doses Per Week For Its Clinical Trials
10/25/2024
Automation and the underlying chemistry of its R327 candidate have helped the antibiotic developer reach notably high production volumes.
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What's Next After FDA's DSCSA Extension?
10/18/2024
Facing growing pressure from industry and Congress, FDA extended its enforcement deadline yet again, which has important implications for manufacturers.
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Data Quality Issues At The Heart Of FDA's DSCSA Troubles
10/18/2024
Industry still struggles to manage complex data requirements, which forced the FDA to once again delay enforcement of the Drug Supply Chain Security Act.
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CDER Wants Your Input On Improving Integrated Reviews
10/17/2024
CDER recently moved from sharing reviews from individual disciplines in public documents to an Integrated Review, which includes conclusions but much less detail.
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The Regulatory Affairs Function Is Evolving. Are You Evolving With It?
10/10/2024
The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the function is growing more complex, and specific AI tools can help regulatory processes.
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Enhanced Risk? EMA Issues New Guidance For OSD Co-processed Excipients
10/9/2024
In recent years, there has been a drive toward the use of co-processed excipients to aid leaner manufacturing. This has prompted the European Medicines Agency (EMA) to develop a new guidance document, Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V). The public consultation period is open until the end of 2024.
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What To Do When Your Regulatory Findings Need Quality Risk Management Action
10/2/2024
More than half of all recent warning letters issued by the FDA include citations for absent or incomplete risk assessments. This article examines what regulators are looking for.
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EMA Issues Draft Guideline On The Development And Manufacture Of Oligonucleotides
9/26/2024
The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides. It includes requirements and considerations related to conjugation, active substance in solution, and more. The consultation period ends Jan. 31, 2025.
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FDA Issues Revised Guidance On Controlling Nitrosamine Impurities In Pharmaceuticals
9/11/2024
The FDA has issued a revised version of its guidance, Control of Nitrosamine Impurities in Human Drugs. This article explores the agency's recommendations, root causes of nitrosamines, and strategies for mitigating their presence in pharmaceuticals.
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EMA Issues New Draft Guideline: Chemistry Of Active Substances
9/3/2024
The European Medicines Agency (EMA) has issued a new draft guideline to set out the type of information required for the manufacture and control of active substances used in a medicinal product. The public consultation period ends Jan. 31, 2025.