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With more cha-ching, will PDUFA V satisfy on the ba-bling?

 
• By Donna Young

The smooth sailing the Prescription Drug User Fee Act (PDUFA) reauthorization process experienced this past year – with the legislation getting through Congress with rare bipartisan support and little opposition in record time – does not necessarily mean there will be calm waters ahead for the US FDA, which must now follow through on the negotiated commitments it made, albeit with a few dollars more in its pocket and some added authorities and flexibility.

The smooth sailing the Prescription Drug User Fee Act (PDUFA) reauthorization process experienced this past year – with the legislation getting through Congress with rare bipartisan support and little opposition in record time – does not necessarily mean there will be calm waters ahead for the US FDA, which must now follow through on the negotiated commitments it made, albeit with a few dollars more in its pocket and some added authorities and flexibility.

Forget about the price tag. Even with the expected more than $4 billion over five years in user fees, making...

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Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 
• By Andrew McConaghie

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 
• By Andrew McConaghie

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

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Syncona Looks To Go Private As Market Decline Deepens

 
• By Andrew McConaghie

While some are calling for Syncona to be wound up, the UK-based company believes many existing and new investors will back the creation of new private fund.

Gilead’s Yeztugo Gets US Approval For Twice-Yearly PrEP

 
• By Alexandra Shimmings

The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.

ASCO: Pushing The Frontiers Of ADCs

 
• By Mary Jo Laffler

Antibody-drug conjugates are a major part of the oncology pipeline, and data presented at the American Society of Clinical Oncology meeting highlight the emergence of new technologies.