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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., As discussed in an earlier post ( here ), CDRH piloted the eSTAR electronic submission template last year. By Allyson B. We look forward to FDA expanding both programs.
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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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.
FDA Law Blog
JULY 7, 2024
FDA regulations define a complaint expansively, to include “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” [2] MDRs must be reported to FDA in electronic format.
GeriPal
FEBRUARY 29, 2024
I actually wrote a blog post about this when we were a blog. We were a blog? Alex: And, they were talking about how they were so annoyed because they felt like they got called so frequently by companies trying to sell them electronic wheelchairs. But I remember having a conversation with them. Remember way back when?
GeriPal
DECEMBER 8, 2022
Integration of Person-Centered Narratives Into the Electronic Health Record: Study Protocol. Connection — The Integration of a Person-Centered Narrative Intervention into the Electronic Health Record : An implementation study. Eric’s blog post on Dignity Therapy from 2011. Bennett, C.R., Schilling, L., Doorenbos, A.
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