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Industry, FDA Agree On Draft User Fee Commitment Letter

Draft commitment and legislative language come one month after agreement “in principle” on MDUFA III reauthorization.

FDA and industry have agreed to a draft commitment letter and proposed legislative language to reauthorize device-related FDA user fees.

The commitment, detailed in documents released by FDA last week, comes one month after the parties reached an agreement “in...

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Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Eleanor Malone

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Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.

In Partnership with Cerba Research

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

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