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Things Are Looking Up On The US Regulatory/Policy Front

 
• By Ashley Yeo

Going in to 2016, it's hard not to characterize the US regulatory and policy environment as positive for the medical device industry. There is a consensus that the FDA premarket review process in 2015 has become, on average, more efficient and more transparent that it was five to 10 years ago. And policymakers, if anything, are focused on furthering that trend.

Going in to 2016, it's hard not to characterize the US regulatory and policy environment as positive for the medical device industry.

There is a consensus that the FDA premarket review process in 2015 has become, on average, more efficient and more...

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

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Early Development Deals: Ipsen's Strategy For Biomarker-Driven Success

 
• By Eliza Slawther

Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.   

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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• By Ashley Yeo

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Medtech Innovators Court London-Based Investors At BioWales 2025

 
• By Ashley Yeo

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Rising Leaders 2025: Metsera’s Whit Bernard’s Musical Path To Biotech Leadership

 
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