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BIO Notebook: US FDA User Fees For AI Regulation, Partnering Strategy Evolves, And More

 
• By Pink Sheet Team

Insights from Day Two of the BIO International Convention in San Diego include user fees potentially supporting the FDA's AI ambitions, the evolving pros and cons of partnering, and J&J's view on dealmaking in 2024.

BIO 2024 Day 2
• Source: Shutterstock

The US Food and Drug Administration likely will need a risk-based approach to reviewing the artificial intelligence aspects of drug applications as the technology becomes more pervasive in regulatory submissions, Center for Drug Evaluation and Research Director Patrizia Cavazzoni said at the BIO 2024 FDA town hall.

As the use of AI in applications increases it will become both economically unrealistic and infeasible from a time perspective...

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BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
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Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

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PharmaMar Withdraws EU Aplidin Filing After Regulatory Rollercoaster

 
• By Eliza Slawther

PharmaMar has voluntarily withdrawn its marketing authorization application for Aplidin to treat multiple myeloma in the EU – almost a decade after it first filed the drug for EU approval and following years of court proceedings.

Italy To Reward Locally Conducted R&D In Innovative Medicines Fund Revamp

 
• By Francesca Bruce

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Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

 
• By Michael McCaughan

The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.