FDA Leadership Changes Reflect Budgetary, Scientific Challenges

FDA has a new chief operating officer and medical officer. The appointments reflect the challenges of a lean budget and calls for a chief scientist from the Institute of Medicine.

FDA has a new operations manager to get it through a tough budget period and into the next user fee cycle, and a long-time FDA official in the senior management position many people wished she always had.

Commissioner Andrew von Eschenbach appointed John Dyer to chief operating officer and deputy commissioner for operations, and Janet Woodcock to the newly created position of chief medical officer on January...

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

More from Market Access

US FDA’s Familiar Drug Pricing To-Do List

 

President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.

Why Hympavzi Secured English Funding For Hemophilia B But Not Hemophilia A

 

Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.

US Most Favored Nations Policy: Higher Drug Spending In Germany Is ‘Difficult To Imagine’

 

Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.

Japan Reimburses 11 New Drugs But Slashes Price Of Others By Up To 20%

 
• By 

Japan's NHI program continues to give and take as 11 new drugs are granted reimbursement, while the prices of others - including three ophthalmic therapies - are cut by up to 20% under a Market Expansion Repricing scheme.

More from Pink Sheet

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By 

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Why Hympavzi Secured English Funding For Hemophilia B But Not Hemophilia A

 

Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.

Europe’s UPC Issues Landmark Ruling On Second Medical Use Claims

 

The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.