Agency IQ

AUGUST 23, 2024

The rule has significant implications for the way that LDTs are regulated in general, but also has additional impact on the use of LDTs in the context of drug development (i.e., There are several high-level takeaways from these updates for drug developers.

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Agency IQ

FEBRUARY 2, 2024

BY LAURA DIANGELO, MPH | JAN 30, 2024 10:25 AM CST Diagnostic regulation: A quick overview Diagnostics products are those intended to identify, signal or detect a specific health condition, infection or disease, or monitor a person’s health or health status. The diagnostics landscape in the U.S.: In-house tests (similar to LDTs in the U.S.,

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Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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Codon

SEPTEMBER 29, 2024

The earliest ones relied on simple linear regression and attempted to correlate genetic variations with observable traits or disease risks — such as drug metabolization rates or cancer susceptibility. It wasn’t a silver bullet to the hard problem of drug development, but it wasn’t too far off either.

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FDA Law Blog: Biosimilars

OCTOBER 13, 2024

Tobolowsky — The Rare Pediatric Disease Priority Review Voucher program has had a bit of a tumultuous history in its 12 short years of existence. Over 50 rare pediatric disease priority review vouchers have been awarded to date. We heard and felt the anxiety from many of our clients about the uncertainty this caused.

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FDA Law Blog: Drug Discovery

FEBRUARY 11, 2025

However, as we suggested in a recent blog post , the statute did not actually provide any limitations on FDAs authority to grant rare pediatric disease designations , only its authority to grant vouchers. In the meantime, the Pink Sheet confirmed that FDA was continuing to review rare pediatric disease designation requests.

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FDA Law Blog: Drug Discovery

DECEMBER 23, 2024

Although the earliest sunset of the year was actually in early December, this day also marked another premature sunset the beginning of the end of the rare pediatric disease priority review voucher program. As we blogged recently, the program has had scheduled sunset dates from its very beginning, which have been repeatedly extended.

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Drug Target Review

MARCH 20, 2025

Its one of the most common heart rhythm disorders and can be caused by conditions like high blood pressure and heart disease, or can sometimes occur without an obvious cause. LILAC is an event-driven study so we do not know exactly when the study will end, but we anticipate having final data in 2026.”

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