CDER, CBER Report More Hiring Gains, But At Slower Rate Than Earlier In Fiscal Year

Pink Sheet infographic shows that while overall growth continues at the drugs and biologics centers, the US FDA still must add many employees to meet user fee-mandated hiring goals.

Now Hiring Sign_707530996_1200.jpg
• Source: Shutterstock

The drug and biologics centers at the US Food and Drug Administration continued increasing their employee counts in the third quarter, but at a slower rate than earlier in the fiscal year, potentially fulfilling Peter Marks’ prediction of an election season slow-down.

More from US FDA

What MAHA Means For US FDA: Prevention Is Not What You Think

 

US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.

Makary’s Reorganization Decision A Turning Point For US FDA?

 

US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.

Pink Sheet Podcast: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems?

Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts.

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.

More from Conferences