Stacy Morrow, MS, RN, PHR’s Post

In the EU, regulatory CMC flexibilities have been implemented for certain licenced biological medicinal products. While the legislative requirements for quality, safety and efficacy still apply, flexible approaches can be taken at critical stages of the product lifecycle, such as postponing some CMC requirements to the post-authorization phase or leveraging of prior knowledge (PrK). Find out more from my colleague David Murray.

In the EU, regulatory CMC flexibilities have been implemented for certain licenced biological medicinal products. While the legislative requirements for quality, safety and efficacy still apply, flexible approaches can be taken at critical stages of the product lifecycle, such as postponing some CMC requirements to the post-authorization phase or leveraging of prior knowledge (PrK). Find out more from my colleague David Murray.

In the EU, regulatory CMC flexibilities have been implemented for certain licenced biological medicinal products. While the legislative requirements for quality, safety and efficacy still apply, flexible approaches can be taken at critical stages of the product lifecycle, such as postponing some CMC requirements to the post-authorization phase or leveraging of prior knowledge (PrK). Find out more from my colleague David Murray.

In the EU, regulatory CMC flexibilities have been implemented for certain licenced biological medicinal products. While the legislative requirements for quality, safety and efficacy still apply, flexible approaches can be taken at critical stages of the product lifecycle, such as postponing some CMC requirements to the post-authorization phase or leveraging of prior knowledge (PrK). Find out more from my colleague David Murray.

In the EU, regulatory CMC flexibilities have been implemented for certain licenced biological medicinal products. While the legislative requirements for quality, safety and efficacy still apply, flexible approaches can be taken at critical stages of the product lifecycle, such as postponing some CMC requirements to the post-authorization phase or leveraging of prior knowledge (PrK). Find out more from my colleague David Murray.

In the EU, regulatory CMC flexibilities have been implemented for certain licenced biological medicinal products. While the legislative requirements for quality, safety and efficacy still apply, flexible approaches can be taken at critical stages of the product lifecycle, such as postponing some CMC requirements to the post-authorization phase or leveraging of prior knowledge (PrK). Find out more from my colleague David Murray.

In the EU, regulatory CMC flexibilities have been implemented for certain licenced biological medicinal products. While the legislative requirements for quality, safety and efficacy still apply, flexible approaches can be taken at critical stages of the product lifecycle, such as postponing some CMC requirements to the post-authorization phase or leveraging of prior knowledge (PrK). Find out more from my colleague David Murray.

In the EU, regulatory CMC flexibilities have been implemented for certain licenced biological medicinal products. While the legislative requirements for quality, safety and efficacy still apply, flexible approaches can be taken at critical stages of the product lifecycle, such as postponing some CMC requirements to the post-authorization phase or leveraging of prior knowledge (PrK). Find out more from my Parexel colleague, David Murray.

In the EU, regulatory CMC flexibilities have been implemented for certain licenced biological medicinal products. While the legislative requirements for quality, safety and efficacy still apply, flexible approaches can be taken at critical stages of the product lifecycle, such as postponing some CMC requirements to the post-authorization phase or leveraging of prior knowledge (PrK). Find out more from my colleague David Murray.

🚀 Unpacking FDA’s Latest Guidance: A Milestone in Medical Innovation! 🚀 The FDA’s new guidance, rooted in the transformative 21st Century Cures Act, marks a pivotal shift in accelerating medical product development. It’s not just a document; it’s a beacon for innovation, offering a practical framework for using Real-World Evidence (RWE) in regulatory decisions. This is where xCures leaps into action! Our approach aligns with the FDA’s vision, especially in harnessing RWE for new drug indications and post-approval studies. We’re at the forefront, navigating these uncharted waters, and translating these guidelines into tangible outcomes. This guidance lights the way for registries in evaluating drug effectiveness and safety. Dive into the full potential of this groundbreaking guidance with us at www.xCures.com. Together, let’s shape a future where medical breakthroughs reach patients faster and more efficiently than ever before! #realworldevidence #registry #realworlddata Mark Shapiro Kenny Wong Glenn Kramer Max Goldstein