1. Pink Sheet
  2. >>Agency Leadership

MedGuide=REMS? Not Always

 
• By Michael McCaughan

FDA and stakeholders agree that MedGuide-only REMS are more trouble than they are worth. The agency has already told two sponsors that they don't need a REMS even though they need a MedGuide--but only because there are other products in the class that don't have REMS.

When FDA approved AstraZeneca PLC/Pozen Inc.'s naproxen/esomeprazole formulation Vimovo on April 30, the approved indications were only for use in arthritis and related indications; this formulation isn't intended to for relief of headaches, like the OTC naproxen brand Aleve.

Still, while Vimovo may not be approved for headache relief, FDA's approval letter prevented one headache for the sponsor: the...

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

Quotable: Top Experts On Policy Hot Topics

 
• By Anabel Costa-Ferreira

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

As US FDA Turns: Can Makary, Prasad And Pazdur Make It Work?

 
• By Michael McCaughan

The FDA leadership drama continues after Richard Pazdur was elevated to drug center director. Can Pazdur, CBER Director Vinay Prasad, and Commissioner Martin Makary get along?

CBER Poised for Research Shakeup As Prasad Makes Unproven Claims About ‘Polluted Science’

 
• By Sarah Karlin-Smith

In an email to staff filled with unsupported accusations about the quality of the center’s research, CBER Director Vinay Prasad said no resources or time should be spent on ongoing projects started before he joined the FDA until discussed with him.

US FDA Cancer Office Keeps Hemorrhaging Staff, Most Land At Industry

 
• By Sarah Karlin-Smith

Merck, Lilly, and Johnson & Johnson are some of the pharma companies who have snagged the many staff leaving the FDA’s oncology positions. The Pink Sheet estimates CDER’s oncology division is operating with about a 20% vacancy rate.

More from Pink Sheet

Trump’s Semaglutide Most Favored Nation Price Will ‘Supersede’ Medicare MFP

 
• By Cathy Kelly

The Medicare negotiated price is slightly higher than the Most Favored Nation price recently announced by the Trump Administration.

AI Boosts Parkinson’s Disease Cell Therapy Development

 
• By Bridget Silverman

Aspen Neurosciences and BlueRock Therapeutics see hope for artificial intelligence to improve the quality of cell therapies to replace dopaminergic neurons in Parkinson's disease.

PhRMA Urges Japan To Maintain Drug Prices Amid MFN Concerns

 
• By Lisa Takagi

While Japan tries to balance its healthcare costs, the major US industry group is concerned reimbursement pricing practices in the country could influence US levels under Trump's MFN policy.