US FDA Ready To Move Forward On Developing Quality Management Maturity Rating System

The US FDA will begin work on operationalizing a Quality Management Maturity rating system following a public vote of confidence from its outside advisory committee. There are plenty of key details still to be worked out.

Filling in the blanks
fda will fill in the blanks on qmm • Source: Shutterstock

The US Food and Drug Administration will move into the process of drafting an implementable Quality Management Maturity rating system after a 2 November public endorsement of the concept from its Pharmaceutical Science & Clinical Pharmacology Advisory Committee.

The committee review amounted to the final stop on FDA’s process to build support at the conceptual level for the QMM proposal. FDA kicked off the 2022 campaign with a...

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 Manufacturing

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

More from Compliance

Austria To Fine Companies For Violating New Drug Stockpiling Rule

 

A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.