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FDA Will Not Review New Applications During Government Shutdown

 
• By Brenda Sandburg

The agency is not accepting regulatory submissions that require an FY 2014 user fee payment during the shutdown; of the 8,180 FDA employees now reporting to work, 74% are funded by user fees.

The government shutdown on Oct. 1 has forced FDA to close its doors to new applications, limiting its review to those already on file.

In response to questions about the impact of the shutdown on agency activities, FDA said that it will not have...

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BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

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.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

US FDA’s Top Cell and Gene Therapy Regulators Forced Out

 
• By Sarah Karlin-Smith

Office of Therapeutic Products Director Nicole Verdun and her deputy Rachael Anatol were escorted out of FDA headquarters on June 18. Disagreements over CAR-T regulation and Capricor’s DMD treatment may be to blame.

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