1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>United States

FDA’s Quality Metrics Initiative Challenged on Enforceability

 
• By Bowman Cox

The pharmaceutical industry won’t let FDA force it to report quality metrics without a fight.

After two years of collaborating on a set of industrywide pharmaceutical quality metrics, FDA and industry are clashing over enforceability.

A rift between the agency and industry groups that surfaced at a public meeting in August has since widened, judging...

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 United States

How Could MFN Pricing Impact Commercial Market?

 
• By Angela Maas

Industry experts forecast the impact of President Trump's Most-Favored Nation drug pricing policy on the commercial insurance industry.

COVID-19 mRNA Vaccine Labels Now Quantify Myocarditis Risk, But ACIP Wants Other Changes

 
• By Sue Sutter

New members of the CDC’s Advisory Committee on Immunization Practices suggested concerns beyond myocarditis, questioning whether test-negative observational studies are giving an incorrect picture of effectiveness.

Medicare’s Combo Products Negotiation Plan Conflicts With US FDA Standards, Firms Argue

 
• By Cathy Kelly

The plan could curtail a period of pricing flexibility for newer subcutaneous versions of important oncology drugs.

US FDA’s ADHD Drug Relabeling Advances A MAHA Priority, Reviving Data Dispute

 
• By Bridget Silverman

Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.

More from North America

Trump Administration Closer to Unprecedented Drug Price Transparency Requirements

 
• By Tim Casey

New rules requiring more granular drug pricing data to be disclosed in machine-readable files will go into effect in 2026.

Orphan Drug Relief Still In Budget Bill But Uncertainty Remains

 
• By Cathy Kelly

The budget reconciliation bill nears final passage without pharmacy benefit manager reforms or provisions that would facilitate access to cell and gene therapies for children, but its Medicaid cuts pose a significant threat to prescription drug access.

How Will Regulatory Filing Winds Blow Globally For Elevidys Following Patient Deaths?

 
• By Francesca Bruce

Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.