On May 15, 2025, FDA will hold an all-day public meeting to obtain input from interested parties for the agency’s report to Congress on pediatric drug development and labeling.

NetraMark Holdings Inc. (the “Company” or “NetraMark”) (CSE: AIAI) (OTCQB: AINMF) (Frankfurt: PF0) a premier artificial intelligence (AI) company transforming clinical trials today announced it has ...

They give us an overview of the pediatric drug development landscape, model-informed drug development, share best practices, and more.This episode is sponsored by Certara. Advertisement ...

Precision BioSciences Inc., a clinical-stage company developing gene editing therapies for diseases with high unmet need, has ...

8. FDA. Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations Guidance for Industry. fda.gov. [Online] May 2023.

In this episode, Max Williamson, a Patient Representative for the UK National Cancer Research Institute, and Karen Rowland Yeo, PhD, Senior Vice President at Certara, discuss the challenges in ...

The Creating Hope Reauthorization Act, which would have extended a program incentivizing pediatric drug development that has already resulted in the development of 65 new medications.

Cancer drug shortages, the problem the administration set plans to alleviate on Monday, are common. Low margins on cheap, generic drugs including chemotherapies have resulted in a fragile supply ...

U.S. President Biden signed a bill last Thursday postponing the sunset date of the rare pediatric disease Priority Review Voucher (PRV) program from September 30, 2024, to December 20, 2024.

Aiming Targeted Drug Development at Rare Pediatric Malignancies The following represents disclosure information provided by the author of this manuscript. All relationships are considered compensated ...

Bonnie says they will ask lawmakers to reinstate those bills, like a program for pediatric drug development that's already produced 65 new medications and an act that would allow low-income ...