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US FDA Quality Metrics Initiative Continues Moving Forward … Quietly

 
• By Derrick Gingery

Despite few public announcements and industry concerns, FDA's Office of Pharmaceutical Quality director says program is not dead.

ine conveyor for labeling and packaging ampoules in boxes
FDA's manufacturing quality metrics program remains a priority, OPQ's director says.

The US FDA's quality metrics program for drug manufacturing facilities may be quiet and potentially undergoing some changes, but has not been abandoned.

Office of Pharmaceutical Quality Director Michael Kopcha said the agency continues to review the myriad of comments received from industry...

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50% Levy On India And Brazil, US Tariffs Leave Global Trade, Forecasts In Disarray

 
• By Vibha Ravi

50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making the forecasting environment for the pharma industry extremely difficult, the Pink Sheet finds in this infographic analysis.

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The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?

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• By Neena Brizmohun

While titanium dioxide is banned as a food additive in the EU, the European Medicines Agency has convinced the European Commission to allow its continued use in the many thousands of medicines in which it is currently used.

UK Medicines Shortages Inquiry Eyes Full Reshoring of Drug Manufacturing

 
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A newly launched UK government inquiry is seeking to learn how viable it would be to bring back domestic control over the entire drug manufacturing pipeline.

More from Pink Sheet

Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 
• By Derrick Gingery

The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?

Off-Patent Drugs Get UK Spotlight, But Picture Is Still ‘Nuanced’

 
• By Urtė Fultinavičiūtė

The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. However, Mark Samuels, CEO of Medicines UK, the trade body representing the off-patent industry, says companies are still face multiple hurdles in the market.

MHRA Investigates GLP-1 And Pancreatitis Genetic Link In Personalized Medicine Push

 
• By Eliza Slawther

The UK drug regulator is collecting data to establish whether patients who are hospitalized for acute pancreatitis after taking a GLP-1 drug have a genetic predisposition to this side effect. If a “clear link” is found, the MHRA would consider regulatory action.