FDA Law Blog

FEBRUARY 23, 2025

Manufacturers must evaluate device changes in the first instance to determine whether a new 510(k) is needed or, instead, whether documentation of the change and rationale for not seeking 510(k) clearance is sufficient. Such assessments are highly individualized and difficult to map onto the few examples provided by FDA in its guidance.

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FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?

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FDA Law Blog

MAY 20, 2021

Investigators likely consult with DEA headquarters about the registrant’s compliance with required reporting and review its registration category, status, and authorized controlled substances to assess whether it may be conducting unauthorized activities. Accountability Audit.

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FDA Law Blog

MAY 20, 2021

Investigators likely consult with DEA headquarters about the registrant’s compliance with required reporting and review its registration category, status, and authorized controlled substances to assess whether it may be conducting unauthorized activities. Accountability Audit.

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FDA Law Blog

SEPTEMBER 20, 2021

requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners). In brief, the process begins with a request for a presubmission informal teleconference (or alternatively, a discussion as part of a pre-sNDA or pre-sBLA meeting). Notable Dates and Timelines – New MAPP published, by Dec.

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GeriPal

MAY 5, 2022

We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. Communication techniques we can use when talking to individuals with hearing loss. But individuals who have hearing loss, there’s several problems. How to screen for hearing loss.

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FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations.

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