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US FDA's Streamlined Hiring Pilot Restarts After Delay

 
• By Kate Rawson

Recruiting for “Cures”-funded positions resulted in two hires, then got an HHS review; onboarding time should be reduced significantly, but finding the money to pay the higher salaries remains a challenge under the new process.

Now Hiring Sign_707530996_1200.jpg

The US FDA has officially launched its “Reimagining Hiring” pilot program approximately one year after Commissioner Scott Gottlieb announced the creation of a streamlined recruitment process to fill open user fee-funded positions at the agency.

The official start of the pilot program on July 30 was postponed approximately six months to allow more time for...

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Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.

Branch Chief Vijay Kumar Named Acting Head Of US FDA’s Cell, Gene Therapy Office

 
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Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.

EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
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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.

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EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
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EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

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.