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Webinar

A Final LDT Rule in April!? Will FDA be prepared?

FDA Law

DECEMBER 11, 2023

Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations. During the October 31, 2023 webinar discussing the proposed rule, stakeholders sought clarity from FDA officials on the Agency’s plan to address the resource gap.

IT Medical Patient-Centered Provider

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law

SEPTEMBER 20, 2021

FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024. based upon the anticipated clinical benefit of earlier patient access to the product.”.

Patient-Centered

Patient-Centered Manufacturing Clinic Provider

Primary Care Digest

A Final LDT Rule in April!? Will FDA be prepared?

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

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