Information and interesting ideas

Topics posted here will be in the realm of bioanalysis and biomarkers as part of new therapeutic development, with the occasional post of scientific topics that I find interesting.

Monday, August 21, 2023

FDA Free Webinar: Understanding FDA Inspections and Data (CMC)

This free webinar will be held September 06, 2023 | 1:00 PM - 3:00 PM ET

Registration is available here:

From the announcement:

During this webinar FDA will provide an overview of drug manufacturing inspections. Participants will gain a general understanding of Current Good Manufacturing Practices (CGMPs) and FDA Inspections. FDA subject matter experts will also demonstrate where inspection data is found on FDA’s website and share how to navigate the FDA Inspection Dashboard.

TOPICS COVERED

    • Overview of FDA’s CGMPs and Inspection Practices
    • How to Find FDA Inspectional Findings

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FDA and CMS issue statement on LDTs: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made

This joint statement notes the evolution of Laboratory Developed Tests (LDTs) from the initial rule and approach the FDA had for oversite, a...