1. Pink Sheet
  2. >>Compliance
  3. >>Manufacturing

US FDA’s ‘Mature’ Approach To Quality: ‘Encourage More, Punish Less’

 
• By Michael McCaughan

Proposed ‘Quality Management Maturity’ rating system would be a way to be more ‘proactive and rewarding’ rather than ‘punitive’ when it comes to oversight of pharmaceutical manufacturing. The initiative is clearly important to the head of FDA’s drug quality office.

Carrot and stick
The US FDA hopes to emphasize carrots instead of sticks in its QMM initiative. • Source: Shutterstock

The US Food & Drug Administration is hoping to build support for its Quality Management Maturity initiative with the message that the goal is to encourage and reward high-quality firms, rather than rely on existing mechanisms to “punish” non-compliance.

In closing remarks after a two-day workshop on the QMM initiative hosted by FDA May 24-25, Office of Pharmaceutical...

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 Manufacturing

More from Compliance

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By Cathy Kelly

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.

US FDA’s Familiar Drug Pricing To-Do List

 
• By Michael McCaughan

President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.