Remove 2026 Remove Documentation Remove Drug Development
article thumbnail

NHC Comments on IRA Guidance Response

Putting Patients First Blog

Driven by the work of the Food and Drug Administration on patient-focused drug development (PFDD), many companies in the biopharmaceutical community have devoted significant resources to better understand patient populations and are working to bring to market products that best suit their needs. Sincerely, Randall L.

article thumbnail

Cloud Computing for Pharma: The Road to Digital Transformation 

Viseven

When COVID hit, the urgent need to accelerate drug development meant shrinking timelines from years to months, with no room for compromises on quality. This innovative approach has brought more than 40 successful drug discovery projects to AstraZeneca. By the end of 2026, the company will be able to analyze two million genomes.

article thumbnail

A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

FDA Law Blog: Biosimilars

We have heard over and over again how the potential for a priority review voucher has allowed small companies with limited resources to invest in the development of drugs for rare pediatric diseases. No rare pediatric disease vouchers could be awarded even to designated applications after September 30, 2026.