FDA Law Blog

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

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Provider IT Engineering Medical 75

FDA Law Blog

MAY 4, 2023

DCTs often include the use of digital health technologies (DHTs), which is technology that can be used to remotely capture and transmit health care information. For example, the draft guidance notes that the trial’s data management plan should include information about the multiple sources of data collection.

Clinic 59

Clinic Telehealth Provider Electronics 59

The Motivated MD

OCTOBER 10, 2024

Disclaimer and Limit of Liability This post (and hopefully its eventual publication) is designed strictly to inform and entertain. I am not liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages. This is how doctors should invest their money.

Finance 52

Finance Individual Management IT 52

PEMBlog

AUGUST 30, 2023

Special thanks to Todd Florin, MD, MSCE who contributed to this post – he is also an expert on respiratory and infectious emergencies. Concerned parents, fueled by a mountain of medical information online, often arrive expecting tests rather than provider expertise to determine the presence or absence of pneumonia.

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Asthma Electronics Utilities Clinical Practice 52

FDA Law Blog

FEBRUARY 28, 2023

We have made improvements to the content of each of these sections over the years and have included additional information to address other guidance documents and the refuse to accept (RTA) checklist, but the general structure has been constant. In other sections of the template, attachments will be needed to include this type of information.

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Provider Electronics IT Complication 52

FDA Law Blog

SEPTEMBER 26, 2022

Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, the list describes alternative mechanisms for complying with the requirements in § 211.165 Testing and Release for Distribution, § 211.166 Stability Testing, § 211.167 Special Testing Requirements, and § 211.170 Reserve Samples. Section 21 C.F.R Section 21 C.F.R

Manufacturing 40

Manufacturing Specialization Provider Medical 40

FDA Law Blog

NOVEMBER 20, 2024

The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting. In the draft guidance, FDA illustrates the need for additional orthogonal data (i.e.,

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Provider Medical Manufacturing Consulting 59

The Motivated MD

NOVEMBER 26, 2024

Disclaimer and Limit of Liability This post (and hopefully its eventual publication) is designed strictly to inform and entertain. I am not liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages. As always… Stay motivated! The Motivated M.D.

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Finance Insurance Individual Medical Advice 52

Physician's Practice

JUNE 20, 2025

For example, practices have adopted electronic medical records (EMR) systems only to find that productivity in the practice ground to a halt. Successful practices have found ways to work around the loss of productivity and ultimately made Electronic Medical Records (EMRs) work effectively in their practices. Make an informed decision.

Management 52

Management Patient-Centered Appointment Patients 52

FDA Law Blog

MAY 20, 2021

At least two investigators must be present during the on-site inspection, but teams can include DEA special agents or task officers from state and local law enforcement and regulatory agencies. Registrants should consult with counsel and their Human Resources departments in deciding whether to provide this information.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

MAY 20, 2021

At least two investigators must be present during the on-site inspection, but teams can include DEA special agents or task officers from state and local law enforcement and regulatory agencies. Registrants should consult with counsel and their Human Resources departments in deciding whether to provide this information.

Management 40

Management Consulting Provider Physicals 40

GeriPal

JULY 19, 2024

I heard this beautiful thing the other day, which was to an electronic medical record, I am not a whole person. And either of those could be given to the patient or an informant. Anna 43:15 I mean, yeah, as I’ve had, I think in general, primary care doesn’t have a lot of information about how to use these things.

Screening 119

Screening Primary Care Patient-Centered IT 119

Medical Xpress

JUNE 16, 2025

More information: ScienceDirect has more on ibogaine. Journal information: Nature Medicine © 2025 HealthDay. The content is provided for information purposes only. The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. All rights reserved.

Mental Health 52

Mental Health IT Medical Specialization 52

FDA Law Blog

DECEMBER 3, 2023

Manufacturers must also ensure that all electronic FDA listings and all NDC listings with the electronic database vendors used to process pharmacy claims, including information about discontinued drugs, are up to date for all applicable drug and selected drug NDCs. 1395w-114c(b)(4)(B)(i). See 42 U.S.C. Phase-in Memorandum at 2.

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Manufacturing Provider IT Electronics 105

Medical Xpress

JUNE 16, 2025

What is known is that special cells in the eye called intrinsically photosensitive retinal ganglion cells (ipRGCs) detect blue light and send signals to the SCN to reset the clock. The content is provided for information purposes only. Neither your address nor the recipients address will be used for any other purpose.

Provider 109

Provider Medical Complication Diabetes 109

The Motivated MD

SEPTEMBER 19, 2024

Disclaimer and Limit of Liability This post (and hopefully its eventual publication) is designed strictly to inform and entertain. I am not liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages. As always… Stay motivated! The Motivated M.D.

Finance 52

Finance Education Individual Healthcare Professional 52

GeriPal

SEPTEMBER 7, 2023

So I make the point, they often say, “Oh, you have this special population,” like pediatrics, where it’s 10% or something. We have the chemo talks tool posted, so people can go there and click and immediately get the information about this. What do they do with this information? Do you worry about that?

Patient-Centered 129

Patient-Centered IT Patients Clinic 129

GeriPal

JULY 28, 2022

Alex: And we are also delighted to welcome Areej El-Jawahri, who is an oncologist at Massachusetts General Hospital as well, who specializes in blood cancers. So I really opted to specialize in lung cancer because I thought that was the appropriate population to build a supportive and palliative care research agenda. Jennifer: Thanks.

Illness 110

Illness Hospital Patient-Centered Patients 110

GeriPal

APRIL 4, 2024

Arguing for the state of Missouri against the Cruzan’s was Ken Starr, who would later be assigned the role of special prosecutor in the investigation of the Clintons (Whitewater, Lewensky, etc). It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Families 112

Families Family Patient-Centered IT 112

GeriPal

FEBRUARY 29, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Anne: Well, speaking of your kids, a very special, sometimes listener, chimed in named Ren Smith. ABIM MOC credit will be offered to subscribers in November, 2024. Alex: Okay. Alex: Yeah.

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IT Patient-Centered Illness Education 126

GeriPal

APRIL 10, 2025

primary palliative care interventions seem to fail, whereas specialized palliative care interventions have a relatively robust track record of success. Corita 09:39 Yeah, so we used the electronic health record, I think, in support. And so we did a similar intervention but using electronic means. Why do so many (most, all??)

Patient-Centered 77

Patient-Centered Hospital IT Patients 77

PEMBlog

MARCH 27, 2024

My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. So my special guest host on this episode is a trainee in pediatrics and medical genetics. I put a lot more information about Dr. Groopman and how to contact her in the show notes.

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Consulting Individual Families Family 59

GeriPal

MARCH 28, 2024

We all, when bombarded with information have to take certain elements of a decision and focus on those; and in the ICU, you can imagine, we’re bombarded with information a lot. Kate: So it was an embedded alert in the electronic health record and they just clicked those two answers very quickly. Why another study?

Consulting 115

Consulting Patient-Centered Patients IT 115

GeriPal

JUNE 9, 2022

We talk with Kate about how despite how far we’ve come in palliative care research, we still don’t have answers to some fundamental questions, such as: Who should get specialized palliative care? They need, they need some, a little bit of information and probably a little more than that, what we like to call an edge. By diagnosis?

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Consulting Patient-Centered Diagnosis Referral 99

GeriPal

APRIL 6, 2023

Alex Practice-PC Program Information: UCSF’s Practice-PC program is now accepting applications for the 2023-2024 year. That’s a lot of information [inaudible 00:35:43], but I share some of that. Thanks to my son Kai for playing the guitar part in 5/4 with strange chords on Riverman by Nick Drake! Alex, is it okay if I ask?

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IT Patient-Centered Families Family 99

GeriPal

SEPTEMBER 5, 2024

They have a special skill, and when they see someone who needs it, they need to use it. That makes it really special for them and for me. And it’s not the same, but it does provide information. And ed imbued in me the concept that physicians are like lifeguards. And I was. I bought into that. Still am when I need to be.

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Patients IT Patient-Centered Hospital 98

FDA Law Blog

JUNE 10, 2025

DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. DEA published the original Special Surveillance in May 1999.

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Specialization Manufacturing Electronics PCP 69

GeriPal

MARCH 27, 2025

It was information about our ACP facilitator. And that included scheduling a visit with a, with a facilitator who had been specially trained. So we have to collect what information we have available from Health Information exchange and electronic health records. What’s in the electronic health record?

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Primary Care IT Clinic Illness 79

GeriPal

JULY 13, 2023

It’s really special to be here and to be talking about this paper, which was really important to Randy. And I think that his research was informed by his clinical practice, his clinical practice was informed by his research. So sharing one electronic health record, but three separate hospitals within them.

Patient-Centered 83

Patient-Centered IT Hospital Patients 83

GeriPal

JULY 20, 2023

If we’re going to get really academic, that’s the umbrella, and that can include a lot of things like including phone calls between a provider and a patient or messages in someone’s electronic medical record. And then video telemedicine is basically one of those pieces in the telehealth umbrella. Eric: Yeah. Joe: Yeah.

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Telemedicine Telehealth Patient-Centered Board-Certified 73