- Sustainability
- DE&I
- Pandemic
- Finance
- Legal
- Technology
- Regulatory
- Global
- Pricing
- Strategy
- R&D/Clinical Trials
- Opinion
- Executive Roundtable
- Sales & Marketing
- Executive Profiles
- Leadership
- Market Access
- Patient Engagement
- Supply Chain
- Industry Trends
Catching Biopharmaceutical Sponsors by Surprise
The FDA has always been concerned about the safety of patients, and they strongly believe that clinical trials are not sufficient to capture all drug related adverse effects.
The FDA has always been concerned about the safety of patients, and they strongly believe that clinical trials are not sufficient to capture all drug related adverse effects. During an update on The Future of FDA’s Drug Safety Program, Andrew C. von Eschenbach stated, “The full magnitude of some potential risks does not always emerge during the mandatory clinical trials conducted before approval.”
In this Applied Clinical Trials article, Moe Alsumidaie discusses FDA’s post-marketing surveillance programs, and how biopharmaceutical sponsors can work with the FDA to identify unreported Adverse Events (AEs).
FDA Approves Subcutaneous Tecentriq Hybreza for All Adult Indications of IV Form of Tecentriq
September 13th 2024Subcutaneous Tecentriq Hybreza will provide patients and physicians increased flexibility for administration of the immunotherapy across approved indications for Tecentriq, including non–small cell lung cancer, small cell lung cancer, and hepatocellular carcinoma.
Beyond the Birthrate: The Societal Costs of Maternal Mortality
September 6th 2024Head of Medical Affairs and Outcomes Research at Organon, Charlotte Owens, MD, FACOG, discusses the most critical changes needed to close the gaps in R&D for maternal health solutions and how feasible they are to make.
