FDA’s Quality Metrics Initiative Challenged on Enforceability

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

More from United States

More from North America

House Gives US FDA More Non-User Fee Funds Than Requested

 

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

Aurobindo, MSN Fail To Beat US Nuplazid Patent Expiring In August 2038

 
• By 

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.

LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 

The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.