1. Pink Sheet

US FDA Office Of Immunology Turnover Tests Updated Review Structure

 
• By Ramsey Baghdadi

A leadership transition in FDA’s Office of Immunology & Inflammation will elevate former rheumatology division Director Nikolay Nikolov to the top spot – with a number of interim and inexperienced leaders in the management layers below.

Personnel Circle
• Source: Shutterstock

A leadership transition in the US Food & Drug Administration Office of Immunology & Inflammation will test the durability of the new drug review structure implemented by the agency’s Center for Drug Evaluation & Research at the start of the current decade.

Former rheumatology division Director Nikolay Nikolov is now acting director of OII, succeeding Julie Beitz, who retired after 30 years...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Agency Leadership

More from Pink Sheet

Business Background Of New CDER Director George Tidmarsh

 
• By Bridget Silverman

George Tidmarsh has extensive experience in the biopharmaceutical industry and led several drugs to FDA approval.

‘Prescription Drugs Are Not Golf Balls’: FTC/DoJ Solicit Clashing Opinions On Patents

 
• By Urtė Fultinavičiūtė

Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?

US FDA Could Seek Stronger Warnings On SSRI Antidepressant Risks During Pregnancy

 
• By Sue Sutter

Testimony during a July 21 ‘expert panel’ could help justify stronger warnings across the class about potential adverse effects on mother and baby. Panelists ranged from clinicians who said depression during pregnancy should be treated, to those who said sadness has been “medicalized."