FDA Law

NOVEMBER 9, 2021

Lenz, Senior Medical Device Regulation Expert — FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here ) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. The ability to track changes and provide and respond to comments is an important part of this process.

Electronics 40

Electronics Physicals Provider Utilities 40

GeriPal

JANUARY 12, 2023

Alex: And we’re delighted to welcome back to the GeriPal Podcast, Stephanie Rogers, who’s a geriatrician and medical director of UCSF’s, age-friendly health systems. Not every hospital or every health system is the same physically or financial incentives or which clinical programs exist and patient demographics.

Hospital 100

Hospital Patient-Centered IT Nurse Practitioner 100

FDA Law

JULY 5, 2023

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. Section II at 2.

Supply Chain 52

Supply Chain Manufacturing Physicals Healthcare 52

PEMBlog

OCTOBER 2, 2024

Join me as I scope out the nuances of gastroesophageal reflux and gastritis and provide practical insights for clinicians in the emergency setting. 2013-0421 Tighe M, Afzal NA, Bevan A, et al. Again, otherwise the diagnosis is based on history and physical examination. J Pediatr Gastroenterol Nutr. 2018;66(3):516-554.

Diagnosis 52

Diagnosis Management IT Patient-Centered 52

The Clinical Problem Solvers

MARCH 4, 2024

Together, our guests offer context around how the medical and carceral systems are deeply intertwined and go hand-in-hand. Explain the significance of abolition medicine, and the role of the medical system in upholding and perpetuating carceral logics.

Community 52

Community Education Patient-Centered Relationship 52

GeriPal

JUNE 19, 2025

This is like, back in 2013, and I joined the faculty at the Icahn School of Medicine at Mount Sinai. So when I joined Sinai In 2013, I was in a different form at that time. Knowing that the community is really underrepresented in sort of our knowledge, what we do, how we provide care that’s truly inclusive and welcoming.

Individual 85

Individual Community IT Chronic Condition 85

GeriPal

MARCH 3, 2022

I am wondering whether it’s the conversations and preparation that’s primary care providers and outpatient providers are having with a lot of these patients and families to either prevent an ICU admission or potentially address their goals, such that they don’t go into the ICU. It was this slow build, I would say.

Patient-Centered 96

Patient-Centered Patients IT Illness 96