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Continuous Manufacturing Back In Second Act

 
• By Bowman Cox

House tries again to promote advanced technology for the return of pharmaceutical manufacturing to the US in post-COVID-19 era.

Watch gears up close
house churns out another continuous manufacturing bill

The new HEROES Act legislation revives a proposal to establish national centers of excellence for continuous pharmaceutical manufacturing that had earlier made it into the US House of Representatives' version of the CARES Act but not the final enacted CARES pandemic relief law.

The HEROES bill (HR 6800) authorizes $100m for the centers of excellence, available until expended. That’s up from the...

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UK Budget: Little Mention Of Pharma, But Some Support For Innovators

 
• By Eliza Slawther

The UK’s autumn budget failed to introduce any widespread changes for pharma, but scale-ups and innovators could benefit from changes to enterprise and investment schemes. Some industry voices warn of underinvestment in the MHRA and innovative medicines.

US FDA Approves First Reformulated Rx Ranitidine, Five Years After Withdrawal

 
• By Malcolm Spicer

The FDA included storage and handling instructions common in labeling in its approval announcement, suggesting concerns remain about the potential for NDMA to form after products are distributed.

Onshoring Incentives Among US FDA’s GDUFA IV Proposals

 
• By Derrick Gingery

During the first GDUFA IV negotiation session, industry representatives were unsure whether the FDA’s idea to create pathways for onshoring incentives fit the scope of the generic drug user fee program.

Generic Drug Onshoring: Bipartisan Support For Federal Procurement Reforms

 
• By Laura Helbling

A Senate hearing on the medical product supply chain suggests there is bipartisan support for ‘buy American’ policies for federal Rx purchases, and for country-of-origin labeling to help those policies expand to the private sector.

More from Compliance

Generic Drug Onshoring: Bipartisan Support For Federal Procurement Reforms

 
• By Laura Helbling

A Senate hearing on the medical product supply chain suggests there is bipartisan support for ‘buy American’ policies for federal Rx purchases, and for country-of-origin labeling to help those policies expand to the private sector.

New Zealand To Approve Drugs In Just 30 Days Under ‘Rule of Two’ Policy

 
• By Neena Brizmohun

New Zealand is also lifting its prohibition on advertising unapproved medicines at medical conferences and trade shows in order to boost its appeal as a host for such events and generate millions of dollars in revenue.

‘Why We Would Do It Again’ – Gilead & Roche On Pioneering Global Initiative For Manufacturing Change

 
• By Vibha Sharma

Gilead and Roche reflect on their experiences with a global initiative that delivered aligned regulatory decisions through joint hybrid inspections and synchronized review of post-approval changes.