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Expanded Access Data Can Support Approval Decisions, US FDA Says

 
• By Kate Rawson

Formal reg not needed, according to agency; officials agree that regulatory flexibility is best way to offer sponsors advice, saying data collected during compassionate use can be helpful in guiding regulatory decisions. 

Exercise
This is not an expanded access program that will help you get your product through the FDA.

The US FDA has a simple message for drug industry sponsors about establishing Expanded Access programs for patients outside clinical trials: compassionate use should be treated as an opportunity to enhance a product’s regulatory or commercial profile, rather than as a potential risk to approval.

Speaking during a Reagan-Udall Foundation meeting on Nov. 19 at FDA headquarters in White Oak, MD, top officials from across...

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Do Policy, Clinical Data, Ocaliva Exit Lend Zydus Helping Hands?

 
• By Vibha Ravi

Intercept’s Ocaliva withdrawal in the US places the spotlight on emerging PBC candidates like Zydus’s saroglitazar, a PPAR agonist that beat both Gilead’s Livdelzi and Ipsen’s Iqirvo on biochemical response in topline results. Will the withdrawal and policy developments boost Zydus’s prospects?

Blueprint For RWE: Aetion Execs Outline Real-World Data Role From Preclinical To Postmarketing

 
• By Bridget Silverman

Sponsors should systematically incorporate real-world evidence generation in all development programs, advises an epidemiology-forward “blueprint” Aetion executives developed.

Clawbacks And Clinical Trial Set Up Are Among UK’s Investment Deterrents

 
• By Francesca Bruce

In the wake of MSD’s decision not to invest $1.35bn in the UK, the Association of the British Pharmaceutical Industry has set out the county’s comparative strengths and weaknesses.

High Clicks, Low Enrollment For Decentralized Arm: Lessons From Europe’s RADIAL Trial

 
• By Vibha Sharma

Despite strong online visibility, Europe's RADIAL trial struggled to convert digital interest from potential study participants into real-world recruitment in its fully decentralized arm.

More from R&D

Merck & Co. Withdrawal Seen As Warning Of UK’s Declining Attractiveness

 
• By Andrew McConaghie

The decision to terminate discovery research was influenced by the US company’s cost-cutting measures but also discontent over the UK’s punitive clawback of revenues.

High Clicks, Low Enrollment For Decentralized Arm: Lessons From Europe’s RADIAL Trial

 
• By Vibha Sharma

Despite strong online visibility, Europe's RADIAL trial struggled to convert digital interest from potential study participants into real-world recruitment in its fully decentralized arm.

Korea’s New Health Minister: ‘Golden Time For The Country To Become A Biopharma Leader’

 
• By Jung Won Shin

Multiple Korean ministries, biopharma companies, and other officials convened at a bio innovation roundtable to discuss strategies to emerge as a global biopharma powerhouse.