1. Pink Sheet
  2. >>Agency Leadership
  3. >>US FDA

Generic Labeling Problems Targeted In US FDA Budget Request

 
• By Derrick Gingery

Agency seeks legislative authority to update outdated generic drug labels when the reference product has been withdrawn.

Generics

The US FDA has proposed settling issues with outdated generic drugs labels through its fiscal year 2020 budget request, asking for authority to change them after they become ostensibly frozen.

The agency wants the ability to update human and animal generic drug labels when the "labeling becomes outdated, including to...

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 US FDA

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 
• By Bridget Silverman

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.

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.

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."

Will Tidmarsh’s Industry Experience Translate As US FDA’s Chief Drug Regulator?

 
• By Sarah Karlin-Smith and Derrick Gingery

The long-time industry executive led several drug approvals but may have a lot to learn about the intimate details of application review and the Center for Drug Evaluation and Research.

More from Agency Leadership