US FDA Quality Metrics Initiative Continues Moving Forward … Quietly

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...

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 Compliance

BIO CEO On Industry And US FDA, Trump’s Vaccine Views And MFN Counter Proposals

 

John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.

UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.

UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

More from Pink Sheet

Canada Unveils Draft List of Essential Drugs For Universal Pharmacare

 

The list of essential prescription drugs and related products will shape Canada’s first national formulary for the country’s universal pharmacare program.

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

Post-BIO Podcast: Thoughts From The Frontlines

Pink Sheet and Scrip journalists reflect on the mood from Boston, the most important takeaways and what’s next for industry.