Continuous Pharmaceutical Manufacturing Bill Hitches A Ride With US FDA User Fee Legislation

US legislation could advance new manufacturing platforms for drugs and biologics with academic R&D and workforce development and in turn spur domestic growth.

US Capitol building framed by tulips in spring
legislation has flowered again; may take root

Legislation promoting the research and development of advanced and continuous pharmaceutical manufacturing technologies has again won US House approval, this time as part of must-pass FDA user fee legislation, which should increase its chances of finally winning Senate approval and becoming law.

The advanced and continuous manufacturing provision is missing from the version of the legislation to renew user fees for another five years that the Senate is considering, but could wind...

More from Platform Technologies

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.

‘Ambitious Platform’ Among EU Proposals For Increasing mHealth Data Use In Regulatory Decision-Making

 

mHealth data generated by smartphones and wearables show potential for enhancing the clinical evidence used in regulatory decision-making, but there are “notable challenges” that may hinder the use of such data, EU regulators say.

US FDA Not Ready For Sponsors Citing Others’ Platforms Yet, Marks Says

 

Many platform designation requests have been from sponsors eager to cite other sponsors’ products, but CBER Director Peter Marks said in an interview with the Pink Sheet his office likely is years away from accepting those applications.

More from Advanced Technologies

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
• By 

Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.