FDA Law

DECEMBER 12, 2023

We know what you must be thinking: “With all this crystal formation, why don’t they call them Glitter boxes?” (Apologies to our readers—word play is FDA Law Blog’s catnip.) RSS is a measurement used to estimate the potential for crystal formation and bladder stone (urolith) growth, a common affliction in cats. Upper bound of 95% CI ≤ 2.5

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FDA Law

JUNE 27, 2023

Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ). By Véronique Li, Senior Medical Device Regulation Expert & Anne K.

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FDA Law

SEPTEMBER 11, 2023

The electronic Submission Template and Resource (eSTAR) program, which we blogged about here and here , also makes the highlight reel given its aim to improve consistency and efficiency in how 510(k)s are prepared. Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway.

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FDA Law

NOVEMBER 6, 2022

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R. Background. Pfizer’s Petition to SCOTUS.

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FDA Law

DECEMBER 16, 2024

We previously discussed the Third Party Review Program in a blog post last year when FDA mentioned its expansion as part of its plan to address the resource gap for review of laboratory developed tests (LDTs) under the LDT final rule. FDA), and to generate data in a format that would streamline FDAs review.

Consulting 52

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FDA Law

JULY 17, 2022

Kirschenbaum — Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package.

Manufacturing 52

Manufacturing Utilities Government Provider 52

FDA Law

NOVEMBER 15, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program.

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