RAPS

Public Meeting to Address FDA’s Benefit-Risk Assessments

The US Food and Drug Administration (FDA) on Tuesday announced it will hold a public meeting on 16 May to evaluate ways to apply FDA’s benefit-risk framework throughout the human drug lifecycle and ...
RAPS

Quantitative Benefit-Risk Assessment: FDA Officials Detail Key Considerations

The US Food and Drug Administration (FDA) is preparing to advance the use of structured benefit-risk assessments in its decision making under its commitments in the recently reauthorized Prescription ...
ascopubs.org

Benefit/Risk Assessment for Breast Cancer Chemoprevention With Raloxifene or Tamoxifen for Women Age 50 Years or Older

Longitudinal Perceptions of Prognosis and Goals of Therapy in Patients With Metastatic Non–Small-Cell Lung Cancer: Results of a Randomized Study of Early Palliative Care The Study of Tamoxifen and ...
National Academies of Sciences%2c Engineering%2c and Medicine

Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products: A Workshop Series

This workshop series provided a venue for stakeholders to discuss structured approaches to characterize and communicate the sources of uncertainty in benefit-risk assessment in drug development and ...
Monthly Prescribing Reference

Amgen Defends Tavneos Benefit-Risk Profile Following FDA Withdrawal Request

US market availability for Tavneos continues as Amgen works with the FDA to address concerns over trial data assessment and known hepatotoxicity risks. Amgen is providing prescribers with updated ...
National Academies of Sciences%2c Engineering%2c and Medicine

Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary

All pharmaceutical products have inherent risks, and their use involves trade-offs between their therapeutic benefits and their risks. However, the public has a limited understanding of the benefits ...