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

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. With regard to clinical trial visits and activities, the draft guidance provides examples of the types of approaches that may be possible with a DCT.

Clinic 59

Clinic Telehealth Provider Electronics 59

The Motivated MD

OCTOBER 10, 2024

So, with this chapter, I hope to briefly touch on the basics of market investing and describe why simple diversification and index fund investing are the most effective ways for busy clinical physicians and healthcare providers to invest with the expectation of long-term gains. Don’t try to beat the market; be the market.

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. Drivers of CXR overuse are myriad and can be thought of at the system, provider, and patient levels. But it’s just a CXR right?

Asthma 52

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.

Provider 52

Provider Electronics IT Complication 52

FDA Law Blog

SEPTEMBER 26, 2022

provides an optional alternative streamlined approach for current good manufacturing practices (cGMPs) for manufacturers of drug-device combination products (CPs). 21 C.F.R. § or that FDA proposes can satisfy the requirements in § 4.4 through alternative or streamlined mechanisms. Section 21 C.F.R Section 21 C.F.R Section 21 C.F.R

Manufacturing 40

Manufacturing Specialization Provider Medical 40

The Motivated MD

NOVEMBER 26, 2024

Use the rules provided above to determine what is right for you. Disclaimer and Limit of Liability This post (and hopefully its eventual publication) is designed strictly to inform and entertain. I am in no way, shape, or form a financial professional, nor does this site provide formalized financial advice.

Finance 52

Finance Insurance Individual Medical Advice 52

GeriPal

JULY 19, 2024

Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. There has to be effective support provided behind any type of screening strategy in order for it to truly be effective. Joe, your thoughts?

Screening 119

Screening Primary Care Patient-Centered IT 119

FDA Law Blog

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. In our experience, investigators review copies of the registrant’s federal and state licenses.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. In our experience, investigators review copies of the registrant’s federal and state licenses.

Management 40

Management Consulting Provider Physicals 40

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.

Management 52

Management Patient-Centered Appointment Patients 52

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

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance.

Manufacturing 105

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. Your feedback is important to us.

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Provider Medical Complication Diabetes 109

The Motivated MD

SEPTEMBER 19, 2024

’ Though it often does not come with the attending salary, medical trainees are getting paid to perform a service, and hospitals provide retirement plans to these individuals. Disclaimer and Limit of Liability This post (and hopefully its eventual publication) is designed strictly to inform and entertain.

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?

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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

FEBRUARY 29, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Alex: Okay.

IT 126

IT Patient-Centered Illness Education 126

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

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

APRIL 10, 2025

Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. primary palliative care interventions seem to fail, whereas specialized palliative care interventions have a relatively robust track record of success. Why do so many (most, all??)

Patient-Centered 77

Patient-Centered Hospital IT Patients 77

GeriPal

MARCH 28, 2024

Kate: The problem is we communicate late, we share prognosis late, we elicit goals and values late, so all the time while they’re in the ICU getting prolonged intensive care, we don’t really know that we’re providing goal concordant care, so we wanted to nudge it a little upstream. Eric: Nudge it. Kate: Nudge it.

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

To provide context, we are joined by Karen Steinhauser, a social scientist at Duke who has been studying spirituality for years (and published one of the most cited papers in palliative care on factors considered important at the end of life , as well as one of my favorite qualitative papers to give to research trainees ). Alex: Yeah.

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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. I know their children.

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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 so a lot of it was the facilitators calling out with the approval of the provider to the patients ahead of time to see, like, you have a visit coming up. And that included scheduling a visit with a, with a facilitator who had been specially trained. This is what I do here.

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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. And we had the date, if it was present in the EHR, to provide that context for the clinician.

Patient-Centered 83

Patient-Centered IT Hospital Patients 83

GeriPal

JULY 20, 2023

What was life for you as a provider pre-pandemic? 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. What did we learn during the pandemic? Eric: Yeah.

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Telemedicine Telehealth Patient-Centered Board-Certified 73