1. Pink Sheet
  2. >>Archive

The Long Shadow of Avandia

 
• By Michael McCaughan

Why is FDA so excited about the Reagan-Udall Foundation? Why is a key legislator so concerned? If both had to answer with a single word, it would be Avandia. The safety questions surrounding GSK's former blockbuster anti-diabetic go a long way towards explaining both the potential for and the political backlash against the foundation.

On paper, Tachi Yamada is a perfect choice to serve on the board of the Reagan-Udall Foundation, the public-private partnership chartered by Congress "to advance the mission of FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety."

As head of the Gates Foundation’s Global Health Program and the former head of GlaxoSmithKline PLC ’s global research &...

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 Archive

More from Pink Sheet

Japan To Cut Leqembi Price By 15% Following Cost Effectiveness Review

 
• By Lisa Takagi

While the government announces eight to 15% cuts to the four products, industry groups urges for its operational improvement without expansion.

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 
• By Bridget Silverman

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.