Newsletter - November 11, 2021
FDA May Soon Require Dose Findings Studies for Oncology Product Approval
Most cancer drugs are clinically evaluated at the highest dose possible, the Maximum Tolerated Dose (MTD), with the assumption that more is better. A white paper co-authored by several FDA oncology drug officials argues that the MTD approach is no longer appropriate and that prior to conducting registration studies, sponsors...Read More
RWE Shows that Short-Course Antibiotic Treatment is Better and Safer
Real world data (RWD) and the resulting real world evidence (RWE) can provide unique and valuable information, otherwise hard to generate, on best practices for patient treatment in real-world health care settings. FDA supported two RWD studies, one in adults and the other in pediatric populations, to evaluate...Read More
FDA May Soon Require Dose Findings Studies for Oncology Product Approval
Most cancer drugs are clinically evaluated at the highest dose possible, the Maximum Tolerated Dose (MTD), with the assumption that more is better. A white paper co-authored by several FDA oncology drug officials argues that the MTD approach is no longer appropriate and that prior to conducting registration studies, sponsors...Read More
RWE Shows that Short-Course Antibiotic Treatment is Better and Safer
Real world data (RWD) and the resulting real world evidence (RWE) can provide unique and valuable information, otherwise hard to generate, on best practices for patient treatment in real-world health care settings. FDA supported two RWD studies, one in adults and the other in pediatric populations, to evaluate...Read More
