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FDA Reform Effort In Congress Taking Expansive View

 
• By Sarah Karlin-Smith

Energy and Commerce’s 21st Century Cures Initiative still focused on pharma even as it dives into communication and health IT.

Even when the House Energy and Commerce 21st Century Cures Initiative takes on topics that span the wider healthcare industry infrastructure and might seem more geared towards discussions of what constitutes a medical device or how to advance electronic health records, lawmakers seem to find a way to bring the drug development and approval process to the table.

Such was the case when House Energy and Commerce Health Subcommittee Chair Joseph Pitts, R-Pa., pressed Amazon VP of Global...

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Cancer Drug Trials Must Be Ready To Pivot As Standards Of Care Shift

 
• By Sue Sutter

Upfront planning is critical to navigating a change in the standard of care while a randomized registrational trial is underway. Sponsors must also be mindful to what patients and clinicians will consider an acceptable comparator arm, a new white paper states.

US FDA’s ‘Plausible Mechanism’ Pathway: A Platform-Based Approach Not Just For Rare Diseases

 
• By Sue Sutter

Manufacturers who succeed in treating several patients with bespoke therapies could leverage platform data to gain marketing approval for similar products in additional conditions, FDA leaders say in a NEJM article that describes five prerequisites for use of the new pathway.

Second-Most Favored Nation? CMS Clarifies Medicaid Price Benchmark In GENEROUS Model

 
• By Cathy Kelly

Demonstration could bring unprecedented transparency into international net prices, at least to CMS.

Hope For Stability, Credibility As US FDA Vet Pazdur Takes Over CDER

 
• By Sarah Karlin-Smith

The appointment of longtime FDA oncology leader Richard Pazdur to lead FDA's Center for Drug Evaluation and Research is being well received.

More from North America

FY 2025 Generic Drugs By The Numbers

 
• By Derrick Gingery

New FDA data shows a potentially concerning drop in ANDA submissions, while the first-cycle approval rate increased.

Biohaven’s Troriluzole And The Era Of Real-Time Complete Response Letters

 
• By Michael McCaughan

US FDA’s rejection of Biohaven’s troriluzole is a huge disappointment for patients with SCA and the company. But it is also a notable example of how communication strategies are changing now that FDA is making its ‘complete response’ letters public.

Makary’s Expert Panel Sparks Regulatory Action For Menopause Hormonal Therapy

 
• By Sarah Karlin-Smith

The requested changes to the class-wide warnings for hormone replacement therapies mark the first time one of Makary’s expert panels sparked regulatory action and could lead to broader scrutiny of their use.