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Erwinaze And The Blessings Of A Missed PDUFA Goal

 
• By Bridget Silverman

CDER missed one user fee goal for action in its 2011 novel approvals – EUSA Pharma’s Erwinaze – and running long allowed the agency and sponsor to find a work-around to a clinical problem that could otherwise have entailed time-consuming new investigations.

While on-time reviews are a key part of the Prescription Drug User Fee Act bargain between FDA and industry, circumstances sometimes conspire to make a missed user fee goal far more desirable than moving to a second review cycle – from both perspectives.

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More from Clinical Trials

India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 
• By Anju Ghangurde

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.

French Bill Could Improve Clinical Research, But Further Action Is Required

 
• By Francesca Bruce

France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.

EU Regulators Push For Better Support For Sponsors On Using Animal Study Alternatives

 
• By Eliza Slawther

The European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies.

More from R&D

New US FDA Roadmap Moves Closer To Animal Testing Alternatives

 
• By Bridget Silverman

New plan to encourage alternatives to animal testing seeks interagency cooperation to meet more aggressive targets for transformational change than the US FDA’s long-standing program.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

New Carbon Monitoring Initiative Could Help Future Proof Clinical Research

 
• By Francesca Bruce

A new European initiative will help trial sponsors better understand whether digitization and decentralized clinical trials of drugs generate less carbon than traditional methods.