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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog: Biosimilars

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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Nucleic acid therapy accelerator

Drug Target Review

About the author Dr William Schafer Group Leader at MRC Laboratory of Molecular Biology William Schafer is a neuroscientist who has investigated conserved principles by which neurons and neural circuits control behaviour.

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FDA Phones a Friend: Joint Statement with CMS Eschews CLIA Modernization and Supports FDA Oversight of LDTs

FDA Law Blog: Biosimilars

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs).

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New molecular insights on medical cannabis

Drug Target Review

Recently, our laboratory discovered a potent partial inhibition of ATX by cannabinoids in a nanomolar range. 2017 Mar 9;60(5):2006–17. Various ATX inhibitors have already been developed by both academic and industrial teams, some of which are currently in clinical trials. Journal of Medicinal Chemistry. 2011 Jul 14;54(13):4619–26.

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Patient Support Services Congress

Drug Channels

Copyright © 2006-2020 Pembroke Consulting, Inc. Doug Donaldson, Senior Director, Product Solutions and Patient Services , Mylan And so many more! Offer not valid on workshop only or academic/non-profit registrations. The content of Sponsored Posts does not necessarily reflect the views of Pembroke Consulting, Inc.,

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Evaluating Impurities in New Drugs to Prevent Delays in Development

The Premier Consulting Blog

Impurities or degradants that exceed qualification thresholds and have not been adequately tested in Good Laboratory Practices (GLPs) toxicology studies are often encountered during development. As they increase further in amount, then they may need to be qualified. link] ICH Q3A (R2). link] ICH Q3B (R2).

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Article FDA Thank You Congress prepares to markup pandemic legislation, all but confirming FDA-related provisions won’t advance

Agency IQ

BY LAURA DIANGELO, MPH JUL 12, 2023 7:14 PM CDT Quick background: the Pandemic and All-Hazards Preparedness Act The Pandemic and All-Hazards Preparedness Act (PAHPA) was originally passed in 2006.

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