Blog Electronics Individual Specialization 
FDA Law Blog
JULY 12, 2022
Mullen — Last month, FDA announced two important steps towards accepting electronic 510(k) submissions. On June 30, individuals with access to the CCP (i.e., While the tool is useful for ensuring the proper electronic formatting for a 510(k) submission, the output still needed to be downloaded and sent to FDA. By Allyson B.
The Motivated MD
OCTOBER 10, 2024
How, then, can any physician find the time to research individual companies and make educated decisions on which publicly traded businesses are undervalued? Instead of investing in individual stocks, why not buy all the most economically impactful stocks in a proportion that reflects an index of the market? We simply cannot.
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The Motivated MD
DECEMBER 18, 2024
I am using our weekly blog posts to create a future book that hopefully will apply to medical trainees and early career physicians looking to build generational wealth, get out of debt, and take control of their financial lives. However, I so commonly see individuals inflate their lifestyle by overextending themselves when buying a home.
FDA Law Blog
MAY 4, 2023
This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ). The draft guidance outlines some of the practical considerations for DCTs with regard to recordkeeping and clinical trial operations.
FDA Law Blog
JULY 10, 2023
In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. an administrative appeal) under 21 CFR 10.75
FDA Law Blog
MAY 20, 2021
Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. They also review CSOS transactions for completeness and accuracy.
FDA Law Blog
MAY 20, 2021
Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. They also review CSOS transactions for completeness and accuracy.
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