Submitting a New Drug Application (NDA) is one of the most resource intensive steps in drug development. For small life science companies, success depends on more than simply reaching the submission milestone. The true measure ...
NDA/BLA
Navigating the Pre-BLA Meeting Process: Securing a Clear Pathway to Success
Preparing for a Pre-Biologics License Application (Pre-BLA) meeting with FDA is a pivotal step in the regulatory journey for sponsors seeking to bring a biologic product to market. This meeting provides an invaluable opportunit...
What are the Different FDA Meeting Types for Drugs and Biologics?
Communication with FDA when developing innovative pharmaceuticals and biologics is a key driver of success. Early and ongoing engagement with FDA can streamline development, reduce risks, and ensure that a company’s regul...
Strong Regulatory Leadership Guidance in Streamlining Product Development
In the fast-paced world of life sciences product development, regulatory submissions are not just a procedural requirement, they are a cornerstone of asset development and a requirement to getting novel and innovative products ...
The Growing Importance of Real-World Evidence in Product Development
At Facet Life Sciences, we understand that the product development landscape is evolving, and one of the key drivers of this evolution is the growing importance of real-world evidence (RWE). It has the potential to accelerate a...
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