When developing a new drug, early engagement with FDA through a Pre-Investigational New Drug (Pre-IND) meeting can set the stage for a smoother regulatory process. This meeting is essential to avoid clinical holds and prevent c...
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Understanding FDA Type A Meetings: Purpose, Process, and Key Considerations
For life sciences companies navigating the FDA regulatory landscape, Type A meetings are generally considered informative meetings focused on resolving issues. They primarily apply to the drug and biologic development process u...
FDA Type D Meetings: A New Option for Targeted, Time-Sensitive Regulatory Guidance
Effective communication with FDA through various FDA meetings is essential for a smooth and efficient drug development process. While Type A, B, and C meetings have long been established as key regulatory meeting types, FDA int...
Understanding Type C FDA Meetings: A Flexible Forum for Regulatory Guidance
When developing a new drug or biologic, timely and strategic engagement with FDA can be the key to a smoother regulatory pathway. While Type A and Type B meetings are often tied to critical milestones, Type C meetings serve as ...
Understanding Type B FDA Meetings
A Type B meeting (also called a Milestone Meeting or an Entitled Meeting) is a formal meeting between the sponsor and FDA to discuss product development and next steps. These meetings are crucial to keep product development mov...
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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