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Farquhar This is the first in a series of blog posts on tips for successfully handling an FDA inspection. Using publicly available examples, these lessons will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection. FD&C Act 501(j).
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Food and Drug Administrations (FDA) diversity and inclusion in clinical trials mandate. PPD Laboratory services Central Lab offers an integrated, flexible, one-stop solution for the collection, management and analysis of lab and study data in the clinical trial ecosystem.
Published June 26, 2025 Ned Pagliarulo Lead Editor post share post print email license An Incyte researcher works in a laboratory. questions vaccine evidence By Delilah Alvarado FDA investigating Elevidys safety; Nektar shares spike on eczema data By BioPharma Dive staff Cassidy challenges RFK Jr. You can unsubscribe at anytime.
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The webinar largely consisted of summarizing the general requirements under Parts 803, 806 and 820.198, which we do not reproduce here ( but see another of our prior blog posts discussing these requirements and their applicable to LDTs in greater detail; you can also find FDA’s slides from the webinar here ).
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