Check back periodically for new posts and analyses. If there’s a specific topic you’d like me to address, feel free to write to me — I’d love to hear your suggestions.
Welcome to the RCSS Blog
I’m excited to start sharing insights and updates on regulatory, CMC, clinical and scientific topics.
My goal is to provide practical information and perspectives to help innovators navigate complex development and regulatory pathways.
Speaking at Bio Innovation 2026
I’m pleased to share that I will be speaking at the Bio Innovation 2026 Annual Conference on April 28, 2026, at the David InterContinental Hotel in Tel Aviv.
My talk, “Expedited Regulatory Pathways for Serious Conditions: Strategies to Accelerate Drug and Biologic Approval,” will focus on how regulatory frameworks can help bring innovative therapies more quickly to patients facing serious diseases.
For many conditions with unmet medical need, time is not a luxury. Expedited pathways play a critical role in enabling earlier access to promising treatments while maintaining the necessary standards of safety and efficacy. Effectively leveraging these pathways is essential to advancing innovation for patients who need it most.
You can find the session details here.
FDA Pre-IND Meeting: Not Just a Checkbox — A Strategic Tool to Reduce Time to Market
By Dr. Nathalie Machluf | March 2026
Early drug development is a critical phase in which key scientific and regulatory decisions can significantly influence the overall development program.
Among the early regulatory interactions available to sponsors, the pre-IND meeting with the U.S. Food and Drug Administration (FDA) represents a particularly important strategic regulatory milestone.
In this article, I outline a 3–5–4 framework to guide sponsors in planning a successful pre-IND meeting.
FDA’s New RDEP: Not Just Clinical Data Matters
By Dr. Nathalie Machluf | October 2025
Last month, in a joint effort, FDA’s CDER and CBER released the Rare Disease Evidence Principles (RDEP), adding it to existing programs aimed at accelerating patient access, such as Fast Track, Accelerated Approval, Priority Review, and Breakthrough Therapy. The RDEP is independent of and not mutually exclusive with Orphan Drug Designation.
This initiative reflects the FDA’s continued commitment to addressing unmet medical needs and improving patient access to innovative therapies.
In this article, I break down the key aspects of this new guideline.