IVR Clinical Concepts (IVRCC)’s Post

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research approved 55 new drugs in 2023. This marks the second-highest count in the past 30 years, with the highest being 59 new drug approvals in 2018 and represents an impressive 50% increase in drugs approved in 2022. Given the high drug development failure rates, advancing a drug candidate to a phase I clinical trial requires a relentless quest for innovation. It is a considerable achievement for any pharmaceutical company or academic research facility. Our latest blog post shares those successes within oncology drug development in 2023, the trends and setbacks, and what’s on the horizon in 2024. Read the blog post now ➡️ https://hubs.la/Q02BxrH10 #Oncology #DrugDevelopment #Bioscience FDA

In 2023, over half of all the novel drugs and biologics approved by the FDA's Center for Drug Evaluation and Research (CDER) and the FDA's Center for Biologics Evaluation and Research (CBER) were to prevent, diagnose or treat a rare disease condition. The recently formed FDA Rare Disease Innovation Hub is a new model of collaboration between #CDER and #CBER - a key indicator of their commitment to explore new approaches for the development and approval of safe and effective drugs and biologics for rare diseases. This Parexel webinar focuses on the desired priorities and outcomes of this initiative from the perspectives of the rare disease clinical research community - including those of a clinician, former regulator and business leaders. Don't miss this webinar full of actionable insights from rare disease experts. ✅ Register now: https://lnkd.in/euD72pKc #FDA #Webinar #RareDiseases #ClinicalTrials

In 2023, over half of all the novel drugs and biologics approved by the FDA's Center for Drug Evaluation and Research (CDER) and the FDA's Center for Biologics Evaluation and Research (CBER) were to prevent, diagnose or treat a rare disease condition. The recently formed FDA Rare Disease Innovation Hub is a new model of collaboration between #CDER and #CBER - a key indicator of their commitment to explore new approaches for the development and approval of safe and effective drugs and biologics for rare diseases. This Parexel webinar focuses on the desired priorities and outcomes of this initiative from the perspectives of the rare disease clinical research community - including those of a clinician, former regulator and business leaders. Don't miss this webinar full of actionable insights from rare disease experts. ✅ Register now: https://lnkd.in/ePn-k7_7 #FDA #Webinar #RareDiseases #ClinicalTrials

In 2023, over half of all the novel drugs and biologics approved by the FDA's Center for Drug Evaluation and Research (CDER) and the FDA's Center for Biologics Evaluation and Research (CBER) were to prevent, diagnose or treat a rare disease condition. The recently formed FDA Rare Disease Innovation Hub is a new model of collaboration between #CDER and #CBER - a key indicator of their commitment to explore new approaches for the development and approval of safe and effective drugs and biologics for rare diseases. This Parexel webinar focuses on the desired priorities and outcomes of this initiative from the perspectives of the rare disease clinical research community - including those of a clinician, former regulator and business leaders. Don't miss this webinar full of actionable insights from rare disease experts. ✅ Register now: https://lnkd.in/ecd8kxpp #FDA #Webinar #RareDiseases #ClinicalTrials

In 2023, over half of all the novel drugs and biologics approved by the FDA's Center for Drug Evaluation and Research (CDER) and the FDA's Center for Biologics Evaluation and Research (CBER) were to prevent, diagnose or treat a rare disease condition. The recently formed FDA Rare Disease Innovation Hub is a new model of collaboration between #CDER and #CBER - a key indicator of their commitment to explore new approaches for the development and approval of safe and effective drugs and biologics for rare diseases. This Parexel webinar focuses on the desired priorities and outcomes of this initiative from the perspectives of the rare disease clinical research community - including those of a clinician, former regulator and business leaders. Don't miss this webinar full of actionable insights from rare disease experts. ✅ Register now: https://lnkd.in/eZB7hiFM #FDA #Webinar #RareDiseases #ClinicalTrials

In 2023, over half of all the novel drugs and biologics approved by the FDA's Center for Drug Evaluation and Research (CDER) and the FDA's Center for Biologics Evaluation and Research (CBER) were to prevent, diagnose or treat a rare disease condition. The recently formed FDA Rare Disease Innovation Hub is a new model of collaboration between #CDER and #CBER - a key indicator of their commitment to explore new approaches for the development and approval of safe and effective drugs and biologics for rare diseases. This Parexel webinar focuses on the desired priorities and outcomes of this initiative from the perspectives of the rare disease clinical research community - including those of a clinician, former regulator and business leaders. Don't miss this webinar full of actionable insights from rare disease experts. ✅ Register now: https://lnkd.in/eXK5Fjq5 #FDA #Webinar #RareDiseases #ClinicalTrials

In 2023, over half of all the novel drugs and biologics approved by the FDA's Center for Drug Evaluation and Research (CDER) and the FDA's Center for Biologics Evaluation and Research (CBER) were to prevent, diagnose or treat a rare disease condition. The recently formed FDA Rare Disease Innovation Hub is a new model of collaboration between #CDER and #CBER - a key indicator of their commitment to explore new approaches for the development and approval of safe and effective drugs and biologics for rare diseases. This Parexel webinar focuses on the desired priorities and outcomes of this initiative from the perspectives of the rare disease clinical research community - including those of a clinician, former regulator and business leaders. Don't miss this webinar full of actionable insights from rare disease experts. ✅ Register now: https://lnkd.in/gAm3mt5K #FDA #Webinar #RareDiseases #ClinicalTrials

In 2023, over half of all the novel drugs and biologics approved by the FDA's Center for Drug Evaluation and Research (CDER) and the FDA's Center for Biologics Evaluation and Research (CBER) were to prevent, diagnose or treat a rare disease condition. The recently formed FDA Rare Disease Innovation Hub is a new model of collaboration between #CDER and #CBER - a key indicator of their commitment to explore new approaches for the development and approval of safe and effective drugs and biologics for rare diseases. This Parexel webinar focuses on the desired priorities and outcomes of this initiative from the perspectives of the rare disease clinical research community - including those of a clinician, former regulator and business leaders. Don't miss this webinar full of actionable insights from rare disease experts. ✅ Register now: https://lnkd.in/eQQAU5rr #FDA #Webinar #RareDiseases #ClinicalTrials

In 2023, over half of all the novel drugs and biologics approved by the FDA's Center for Drug Evaluation and Research (CDER) and the FDA's Center for Biologics Evaluation and Research (CBER) were to prevent, diagnose or treat a rare disease condition. The recently formed FDA Rare Disease Innovation Hub is a new model of collaboration between #CDER and #CBER - a key indicator of their commitment to explore new approaches for the development and approval of safe and effective drugs and biologics for rare diseases. This Parexel webinar focuses on the desired priorities and outcomes of this initiative from the perspectives of the rare disease clinical research community - including those of a clinician, former regulator and business leaders. Don't miss this webinar full of actionable insights from rare disease experts. ✅ Register now: https://lnkd.in/eMpz9h5r #FDA #Webinar #RareDiseases #ClinicalTrials

In 2023, over half of all the novel drugs and biologics approved by the FDA's Center for Drug Evaluation and Research (CDER) and the FDA's Center for Biologics Evaluation and Research (CBER) were to prevent, diagnose or treat a rare disease condition. The recently formed FDA Rare Disease Innovation Hub is a new model of collaboration between #CDER and #CBER - a key indicator of their commitment to explore new approaches for the development and approval of safe and effective drugs and biologics for rare diseases. This Parexel webinar focuses on the desired priorities and outcomes of this initiative from the perspectives of the rare disease clinical research community - including those of a clinician, former regulator and business leaders. Don't miss this webinar full of actionable insights from rare disease experts. ✅ Register now: https://lnkd.in/dmEFNVQq #FDA #Webinar #RareDiseases #ClinicalTrials