FDA Law Blog

DECEMBER 4, 2023

Pharmacists’ Corresponding Responsibility A controlled substance prescription, to be valid, must be issued for “a legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” The government asserted additional allegations that are outside our scope. Complaint ¶ 58. Complaint ¶ 59.

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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.

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Finance Insurance IT Individual 52

FDA Law Blog

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

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FDA Law Blog

FEBRUARY 9, 2024

We previously blogged on the draft guidance ( here ) and on FDA’s broader framework for Digital Health Technologies (DHT) ( here and here ). However, in general, FDA does not intend to request machine or raw data that require electronic processing to be understood in an inspection.

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FDA Law Blog

APRIL 19, 2022

Houck — Effective May 11, 2022, the Drug Enforcement Administration (“DEA”) will require all applications and renewals for registration to be submitted electronically. DEA noted that the National Association of Chain Drug Stores (“NACDS”) and three other individuals commented on the proposed rule. By Larry K. 1,030 (Jan.

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Electronics Individual IT 75

FDA Law Blog

MARCH 7, 2024

The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. Both documents also note that FDA may request copies of the DMC meeting records when the study is completed, and access to the electronic data sets used for each set of interim analysis.

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FDA Law Blog

JUNE 21, 2023

enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., How can the FDA facilitate individuals accessing medical technologies in remote locations when they are unable or unwilling to access care in clinical settings?

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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.

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Clinic Telehealth Provider Electronics 59

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. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. FDA Day (in calendar days) FDA Actions Day 1 FDA receives 510(k) submission.

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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.

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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.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

SEPTEMBER 27, 2023

The new draft guidance states that individuals expected to have a more peripheral role (such as to answer one possible question) may participate virtually to save room for the “core” attendees. In responding to meeting requests, FDA still reserves the right to determine what format is most appropriate.

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IT Manufacturing Provider Clinic 64

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?

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FDA Law Blog

FEBRUARY 7, 2024

Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines.

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FDA Law Blog

DECEMBER 18, 2022

Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction. Summary malfunction reports should be submitted electronically on Form FDA 3500A.

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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.

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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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PEMBlog

MARCH 27, 2024

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families. References Jeanmonod R, Asuka E, Jeanmonod D.

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GeriPal

DECEMBER 15, 2022

And so mine is here at the University of Colorado system, so a non-VA system, so different electronic health records, we have Epic. And so began the journey of, okay, how can we emulate what they’re doing with a different electronic health record program? You did write a blog post about him though, Eric.

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IT Patient-Centered Healthcare Illness 105

FDA Law Blog

JANUARY 8, 2023

If a researcher wishes to change those research elements, they must notify DEA via registered mail or electronically within 30 days before implementation. If a change of cannabis quantity does not impact other factors, researchers must notify DEA by registered mail or electronically and the agency must respond within 3 days.

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GeriPal

SEPTEMBER 19, 2024

Alex 21:31 Blog post, if we’re talking about the same study, was like, fast food palliative care, in and out palliative care, something like that. Or the article that, the fast food article, to use the parlance from the blog post. This is Eric Widera. Alex This is Alex Smith Eric A nd Alex, who do we have with us today?

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