1. Pink Sheet

FDA’s Robyn Bent On The Evolution of Patient-Focused Drug Development

 
• By Brenda Sandburg

The director of the agency’s patient-focused drug development program talks to the Pink Sheet about how the program has improved the development and evaluation of new drugs, initiatives underway, and plans to standardize and harmonize the process.

PFDD decade
Director of US FDA's patient-focused drug development program talks about its accomplishments and future initiatives • Source: Shutterstock

The pharmaceutical industry and patient advocacy groups have been avidly following the progress of the US Food and Drug Administration’s patient-focused drug development program since its launch 10 years ago. The goal of PFDD is to help ensure that patients’ experiences, perspectives, needs and priorities are incorporated throughout the drug development process and regulatory evaluation.

Under a commitment made in the 2012 reauthorization of the Prescription Drug User Fee Act (PDUFA V), the agency began holding a series of meetings with patients and stakeholders that...

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UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 
• By Eliza Slawther

In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials Andrea Manfrin tells the Pink Sheet what sponsors can expect from the new regulation.

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 
• By Barnaby Pickering

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

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MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By Cathy Kelly

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.