Twenty Questions: How Should The US FDA Regulate Distributed Drug Manufacturing?

What happens when manufacturing plants are moving targets? When quality systems are at once more centralized and dispersed? When plant operators are health care workers? Agency wants input before settling on the answers.

20 questions
fda looking for the answers on distributed manufacturing • Source: Shutterstock

A discussion paper from the US Food and Drug Administration poses 20 questions to stakeholders for early input in 11 areas of consideration on its plans to develop a regulatory framework for distributed drug manufacturing, including manufacturing at the point of care.

The initiative could play an important role in facilitating a transformation from a highly globalized industry to one that’s far...

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 Platform Technologies

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.

Elevidys Helps Sarepta To First US FDA Platform Technology Designation

 

Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.

US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell Shuttle

 

Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA

UK MHRA Consults On The Way For Personalized mRNA Cancer Therapies

 

The UK’s drug regulator is developing a “clear and streamlined” regulatory pathway for individualized cancer mRNA immunotherapies.

More from Advanced Technologies

US FDA’s Elsa AI Platform Is Not Guiding Regulatory Decisions, Official Says

 
• By 

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

Branch Chief Vijay Kumar Named Acting Head Of US FDA’s Cell, Gene Therapy Office

 

Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.