FDA Law

SEPTEMBER 14, 2022

Mullen — As promised in our posts from earlier this summer ( here and here ), we are back to report on our assessment of CDRH’s electronic submission process through its Customer Collaboration Portal (CCP). Say goodbye to your thumb drives and CDs – the CCP electronic submission process couldn’t be easier.

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Electronics Specialization IT Medical 59

FDA Law

JULY 12, 2022

Mullen — Last month, FDA announced two important steps towards accepting electronic 510(k) submissions. As discussed in an earlier post ( here ), CDRH piloted the eSTAR electronic submission template last year. Being able to submit completely electronically would be a huge benefit in terms of efficiency and timing for applicants.

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Electronics Individual Specialization Physicals 52

The Medical Futurist

JUNE 21, 2025

However, things are moving fast, and success doesn’t come easy for the pioneers of any medical field. Scientists at Columbia University Medical Center and the University of Iowa used CRISPR to repair a genetic mutation responsible for retinitis pigmentosa in induced pluripotent stem cells derived from a patient with the disease.

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Diabetes Patient-Centered IT Patients 98

Physicians Alliance of Connecticut

JUNE 2, 2025

At the Physicians Alliance of Connecticut, we have an ongoing need for professionals in a wide range of roles, from entry-level support staff to seasoned medical professionals. They also require little or no previous experience in a medical office setting (though experience in other fields can be an asset).

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Healthcare Nurse Practitioner Primary Care Physician Primary Care 52

FDA Law

OCTOBER 5, 2022

Now, according to the Center’s announcement, anyone may request access to the CCP and begin filing premarket submissions electronically. On October 3, 2022, CDRH announced the expansion of this program. CDRH’s website provides a link to request access to the CCP ( here ).

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Electronics Utilities Specialization IT 59

FDA Law

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. KP Medical Device Consulting LLC

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Provider Medical Manufacturing Consulting 59

The Clinical Problem Solvers

MARCH 14, 2025

Simon is a pediatric addiction medicine psychiatrist at Boston Children’s Hospital; an assistant professor in psychiatry at Harvard Medical School; a recent Commonwealth Fund fellow in health policy at Harvard University; and the medical director of Wayside Youth & Family Support Network. 

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Mental Health Community Patient-Centered Hospital 52

Permanente Medicine

MAY 20, 2025

Khang Nguyen, MD, chief transformation officer of the Southern California Permanente Medical Group, discusses how AI can increase clinicians’ joy in medicine and improve patient outcomes with Chris Grant, chief operating offer and executive vice president of Kaiser Permanente, The Permanente Federation, and host of the Permanente Medicine Podcast.

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Patient-Centered Patients IT Medical 52

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. Infuse your budget, buy a new electronic, place it in cryptocurrency, whatever.

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Finance Insurance Individual 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

Aspiring Minority Doctor

MARCH 26, 2021

Plus, my previous experience applying to medical school taught me it only takes one interview to make it in (shout out to PCOM Georgia for being my sole medical school acceptance all those years ago!). I already knew that I liked the residents, staff, program director, and area, so I felt good about the invite.

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IT Families Family Electronics 52

The Motivated MD

NOVEMBER 26, 2024

As many learn throughout their medical training, we are often relocated every few years. Four years in medical school. Far too many people, medical trainees and physicians alike, succumb to the false narrative that you need to own a home to build wealth, and that is not true. These posts may contain affiliate links.

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Finance Insurance Individual Medical Advice 52

The Motivated MD

OCTOBER 10, 2024

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. Standard Disclaimer: None of the information on this website is meant as individualized financial or medical advice. These posts may contain affiliate links.

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Finance Individual Management IT 52

FDA Law

SEPTEMBER 26, 2022

Lenz, Principal Medical Device Regulation Expert & Holly N. requires generally that manufacturing of a combination product (CP) must comply with the applicable current Good Manufacturing Practice regulations (cGMPs) for all of its components ( i.e., a drug/device CP must follow the cGMPs for drugs as well as those for medical devices).

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Manufacturing Specialization Provider Medical 40

FDA Law

MAY 4, 2023

In a CDER Conversation regarding DCTs and DHTs , Leonard Sacks, Associate Director for Clinical Methodology in CDER’s Office of Medical Policy, noted that there is a risk that technical hurdles could skew a trial population to a “younger and more tech savvy” population compared to the actual patient population.

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Clinic Telehealth Provider Electronics 59

Physician's Practice

JUNE 20, 2025

Reynolds Blog Article Innovative medical practices thrive by embracing change, prioritizing patient care and learning from setbacks to enhance success and satisfaction. For example, practices have adopted electronic medical records (EMR) systems only to find that productivity in the practice ground to a halt.

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Management Patient-Centered Appointment Patients 52

GeriPal

JULY 19, 2024

We didn’t have medications that were effective with a few side effects. I heard this beautiful thing the other day, which was to an electronic medical record, I am not a whole person. As my colleague mentioned, I am not a whole person to my medical record, I am a collection of codes. We’re very datified.

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Screening Primary Care Patient-Centered IT 120

FDA Law

FEBRUARY 28, 2023

Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. By Adrienne R. The guidance describes twenty sections to be included in a Traditional or Abbreviated 510(k).

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Provider Electronics IT Complication 52

FDA Law

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

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Annals of Family Medicine

NOVEMBER 20, 2024

The Centers for Disease Control and Prevention recommends discussing family planning and preconception counseling at the domestic medical exam (DME), yet there is little guidance on specific counseling needs in this population. Special attention must be paid to the gaps in care and the risk of infectious diseases in this population.

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Family Medicine DO Complication Families 130

Medical Xpress

JUNE 16, 2025

The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. Learn more Your name Note Your email address is used only to let the recipient know who sent the email. Neither your address nor the recipients address will be used for any other purpose. What are the consequences?

Mental Health 52

Mental Health IT Medical Specialization 52

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 information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. What are the consequences?

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Provider Medical Complication Diabetes 109

The Motivated MD

SEPTEMBER 19, 2024

A study by Johns Hopkins in 2016 found that medical errors may potentially be the third leading cause of death nationwide. ’ 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. So yes, humans make mistakes.

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Finance Individual Education Healthcare Professional 52

Georgetown Pediatrics & Family Medicine

FEBRUARY 10, 2023

In addition to a special day called Valentines, I would like to bring awareness to why we should keep our hearts healthy. There are medications that could be prescribed to help with your nicotine cravings. Refill Your Prescriptions: Follow up with your physician on necessary medications. There is no easy way to broach this.

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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.

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Illness Hospital Patient-Centered Patients 111

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. So pretty soon, I hope, we’ll be able to do this all electronically by anyone who wants to. He had a very aggressive lymphoma, highly aggressive, with a lot of different medical conditions.

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Patient-Centered IT Patients Clinic 130

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.

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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). The hospital refused without a court order, and the case eventually made its way to the Supreme Court. I’m going to go to you Bernie on this.

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Families Family Patient-Centered IT 113

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. Brad’s not a pediatric medical geneticist. So my special guest host on this episode is a trainee in pediatrics and medical genetics. And you’re thinking, hey!

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Consulting Individual Families Family 59

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??)

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Patient-Centered IT Hospital Patients 78

GeriPal

MARCH 28, 2024

Kate: So it was an embedded alert in the electronic health record and they just clicked those two answers very quickly. And that helped them focus on that instead of, say, the blood pressure, the vasopressors or the ventilator settings that day. Eric: And how did you do that? Why another study?

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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? I was always critical care bound since medical school. I’m controlling everything your placebo versus medication trials.

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Consulting Patient-Centered Diagnosis IT 100

GeriPal

APRIL 6, 2023

A friend of GeriPal, and prior guest, Guy Micco commented today that we need an RCT for chaplaincy is like the idea that the humanities need to justify their value in medical training: “It’s like being told to measure the taste of orange juice with a ruler.” Really important person, who later in his life got very interested in healthcare.

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IT Patient-Centered Families Family 99

GeriPal

SEPTEMBER 5, 2024

And he’s also chaired the California Pacific Medical Center’s ethics committee since 1985. Bill 16:55 First of all, I just have to go back to Dax, because Dax in 1973 is when I first came out here as a senior medical student and met Al Johnson. That makes it really special for them and for me. And I was.

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Patients IT Patient-Centered Hospital 98

FDA Law

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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GeriPal

AUGUST 15, 2024

We discuss: What is considered a hate incident, how is it tracked, what do we know about changes over time The wider impact of Anti-Asian hate on older Asians, who are afraid to go out, leading to anxiety, social isolation, loneliness, decreased exercise, missed appointments and medications. Eric 14:41 You mentioned the study.

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GeriPal

MARCH 27, 2025

But most people with dementia are initially diagnosed and medically managed in primary care, and they really desire clinicians to initiate these conversations but there are a number of really important barriers for these conversations taking place. And that included scheduling a visit with a, with a facilitator who had been specially trained.

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Primary Care IT Clinic Patient-Centered 80