Health Law Advisor

APRIL 4, 2023

Continuing my three-part series on FOIA requests using a database of over 120,000 requests filed with FDA over 10 years (2013-22), this month’s post focuses on sorting the requests by topic and then using those topics to dive deeper into FDA response times. In the post last month, I looked at response times in general.

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Health Law Advisor

MAY 2, 2023

In prior posts here and here , I analyzed new data obtained from FDA through the Freedom of Information Act about FOIA requests. Word Count and Importance of Topic Keywords As I explained last month, some of those topics are easier to understand and interpret than others. Here’s what I found. Who is asking what?

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Exeed Regulatory Compliance

FEBRUARY 25, 2020

Regulatory Breakthrough In a small step towards achieving the vision of interoperable medical devices, the FDA has recently authorized marketing of a novel software medical device using the De Novo Classification. the FDA expects for interoperable devices.

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Pharmacy Law Blog

MARCH 13, 2018

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. To learn about a similar case involving a Florida compounding pharmacy, click here to read one of my prior blogs.

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Health Law Advisor

SEPTEMBER 5, 2023

It’s common for a client to show up at my door and explain that they have performance data on a medical device they have been testing, and for the client to ask me if the performance they found is adequate to obtain FDA clearance through the 510(k) process. 70% seems to be a sort of floor to what FDA will consider.

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Health Law Advisor

MAY 3, 2022

We have just gone through an extraordinary two years where, in unprecedented fashion, FDA’s inspection process was essentially shut down. Further, from a warning letter standpoint, without inspection data, FDA focused in other compliance realms than it typically might. Just a short while ago FDA recommenced inspections.

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