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Federal District Court Vacates FDA’s Laboratory Developed Tests Final Rule

FDA Law Blog: Biosimilars

Jordan ordered that FDAs Laboratory Developed Tests (LDT) Final Rule be vacated and set aside, in its entirety. Their case was later consolidated with a similar lawsuit filed by the American Clinical Laboratory Association (ACLA) and HealthTrackRX Indiana, Inc. By Steven J. Gonzalez On March 31, 2025, U.S.

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Daiichi Sankyo, with new data, to seek FDA approval of lung cancer drug

BioPharma Drive: Drug Pricing

The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.

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FDA Inspections: Lesson 1 – Interviewing Employees

FDA Law Blog: Biosimilars

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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More Medical Lab Tests Will Soon Face Federal Scrutiny, FDA Says

Drugs.com

MONDAY, April 29, 2024 -- Laboratory tests used by millions of Americans are soon to be classified as medical devices, and as such be regulated by U.S. Food and Drug Administration, the agency announced Monday.The new rule does not apply to tests.

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FDA Programs to Support Advanced Manufacturing: Where Innovation Meets Regulation

The Premier Consulting Blog

It is recognized, however, that there is a learning curve across the industry and FDA that is inherent to the development of such novel technologies. To prevent this learning curve from becoming a roadblock on the path to regulatory approval, the FDA has developed several collaborative programs to support advanced manufacturing.

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FDA Abandons Its Defense of the LDT Rule, But is It Signaling an Increase in RUO Scrutiny?

FDA Law Blog: Biosimilars

Michael Laposata and the Association for Molecular Pathology in the recent LDT litigation, the Federal, Food, Drug, and Cosmetic Act does not authorize FDA to regulate LDTs as medical devices. Just before this decisive event, though, FDA released a relatively rare Warning Letter to a manufacturer of research use only (RUO) reagents.

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FDA Can’t Reclassify Its Way Out of Reviewing 100,000 LDT Submissions

FDA Law Blog: Biosimilars

Mullen — On January 31, 2024, FDA announced its intent to initiate the reclassification process for most in vitro diagnostic (IVD) products that are currently class III (high risk) into class II (moderate risk). This is to say nothing of the expected doubling of annual device submissions FDA expects it will then receive on an ongoing basis.

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