Regulatory approval

Regulatory approval

Case Study

ISS/ISE Submission for an Investigational Drug Targeting Macular Disorders

March 4, 2025
Blog

Two Challenges Most Rare Disease Trials Face – and How to Avoid Them

February 26, 2025
Podcast

The FDA’s Project Optimus | Episode 4: Designing Randomized Trials for Dose Optimization

February 12, 2025
Podcast

The FDA’s Project Optimus | Episode 3: Role of PK/PD in dose finding and dose optimization

February 4, 2025
Webinar

Navigating FDA’s expectations for drug approval

November 28, 2024
Podcast

Podcast Series: Accelerated Approvals – Introduction

May 14, 2024
Webinar

Good Morning Meeting | Optimizing the Transition from early to late phase trials in oncology

September 19, 2023

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