FDA Law Blog

MARCH 6, 2023

Part 820 with a newly named Quality Management System Regulation (QMSR) (see here ). The proposed rule was published on February 23, 2022 and was first heralded by FDA in 2018 and introduced in the Spring 2018 regulatory agenda. It is noteworthy that the one-year anniversary of the proposed rule has come and gone.

Manufacturing 105

Manufacturing Management Medical Provider 105

PEMBlog

OCTOBER 31, 2024

Caution While this study provides important insights, it is worth noting that probiotics may still play a role in other health contexts. However, for pediatric gastroenteritis, the evidence suggests they do not provide significant benefits. 2018 Nov 22;379(21):2002-2014. N Engl J Med 2018; 379:2015-2026. N Engl J Med.

Hospital 105

Hospital Illness Patients Provider 105

Physician's Weekly

JUNE 25, 2025

Insurance companies have promised changes like these before, in 2018 and 2023, but many didn’t follow through, Dr. Mehmet Oz , head of the Centers for Medicare & Medicaid Services (CMS), said. Insurers must provide clearer explanations when care is denied and explain how patients can appeal.

Insurance 52

Insurance Patient-Centered Electronics Physicals 52

My Green Doctor

APRIL 4, 2025

from 2000 to 2018 among people over 65 years old. Heather Massey, Sustainability Programs Manager hmassey@mygreendoctor.org (469) 877-4608 Make the Pledge Today! If doctors, nurses, and practice managers highlight the connection between environmental factors and patient well-being, people listen—and they take action.

Healthcare Professional 52

Healthcare Professional Healthcare Community Medical Advice 52

Common Sense Family Doctor

DECEMBER 14, 2024

Concerns about overdiagnosis of clinically insignificant prostate cancer through prostate specific antigen (PSA) screening motivated the 2018 American Academy of Family Physicians’ (AAFP) recommendation against routine screening for prostate cancer. Explaining the AAFP’s position, Drs.

Routine Screenings 52

Routine Screenings Screening Complication Diagnose 52

FDA Law Blog

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

FDA Law Blog

NOVEMBER 20, 2024

Since the first issuance of FDA’s guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in 2016, sponsors submitting premarket submissions to FDA have had the option of using these techniques to evaluate certain biocompatibility endpoints.

Provider 59

Provider Medical Manufacturing Consulting 59

Aspiring Minority Doctor

MARCH 14, 2022

I was fortunate to know in advance I would not be matching, but having to manage patients and scrub into cases in between going through the process of applying to unfilled programs didn’t make things any better. The second time I didn’t match, I was in the middle of my original intern year on a busy surgery service.

Medical Student 52

Medical Student Medical Management IT 52

PEMBlog

APRIL 22, 2025

While we pride ourselves on providing high-quality care for all children, we must acknowledge that the noisy, fast-paced, and unpredictable environment of the ED can be especially distressing for autistic patients. Medical Management of Children With Autism in the Emergency Department. 2018 May/Jun;79(3):17r11506. Pediatrics.

Families 77

Families Family Patient-Centered Physicals 77

FDA Law Blog

DECEMBER 2, 2024

We noted that the draft guidance’s discussion on determining a device’s contact duration raised concern as it contradicted ISO 10993-1:2018, Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process. the new draft guidance and ISO 10993-1: 2018) leads to more uncertainty for sponsors.

Consulting 52

Consulting Medical Management Specialization 52

PEMBlog

OCTOBER 18, 2024

When patients with DMD present in the Emergency Department (ED), an understanding of the nuanced aspects of their care is essential for optimal management. Steroid Use and Ambulation Steroids are a mainstay in DMD management, typically starting around ages 3 to 4. Below are key considerations based on current best practices.

Patients 52

Patients Complication Management Consulting 52

FDA Law Blog

DECEMBER 16, 2024

The final guidance looks much like the prior draft and is intended to satisfy FDAs obligation to issue final guidance on consultations with persons under section 565(i) of the FD&C Act and also to provide clarity on use of third party emergency use authorization (EUA) review. Fiscal Year 2023 showed similar performance.

Consulting 52

Consulting Manufacturing Utilities Provider 52

BMJ

JULY 17, 2020

As previous research has found, providing factual information helps tremendously in addressing misconceptions and myths about infectious diseases, the latter of which can seriously undermine implementation of preventive measures. Shaanxi, Xi’an, China: Shaanxi Normal University; 2018. Scholars such as Wen et al.

Community 40

Community Individual Physicals Finance 40

FDA Law Blog

MARCH 6, 2022

Part 820, with a newly named Quality Management System Regulation (QMSR). The QMSR omits many of the specific QSR requirements that currently appear in the regulations, and instead incorporates by reference an international standard for medical device quality management systems.

Manufacturing 52

Manufacturing Management Medical Provider 52

The Clinical Problem Solvers

DECEMBER 16, 2020

However, the diagnostic approach used to determine changes in clinical management of renal disease (i.e. Additionally, research has shown that using symptom-prompted modifications to management, in the context of shared decision-making, can improve outcomes. September 12, 2018. link] Tsai J. Scientific American. Race Matters?

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

SEPTEMBER 7, 2022

The report states that for fiscal year 2021, there were 4,451 CDER drug manufacturing sites, which is a 3% increase over fiscal year 2018, the only comparison year provided. Number of Manufacturing Sites and Registered Products. So stay tuned!

Manufacturing 59

Manufacturing Provider Management IT 59

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). FDA published a proposed list on June 13, 2018 (83 FR 27609), which we blogged about here. 21 C.F.R. § or that FDA proposes can satisfy the requirements in § 4.4

Manufacturing 40

Manufacturing Specialization Provider Medical 40

GeriPal

JUNE 8, 2023

Our last podcast was with Laura Petrillo in 2018 – 5 years ago seems ancient history – though many of the points still apply today (e.g. And yet we’re also in a different place in diabetes monitoring and management. Eric: And you can probably tell already, the topic at hand is diabetes management in late life.

Diabetes 73

Diabetes Management Patient-Centered Families 73

FDA Law Blog

DECEMBER 11, 2023

This is based on FDA’s reported 2018 review of the CLIA database. [2] This is 50% greater than the 2018 numbers relied upon by FDA in its estimates. [3] Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations.

IT 69

IT Medical Patient-Centered Provider 69

Annals of Family Medicine

NOVEMBER 20, 2024

Context As the population ages, access and continuity of primary care with the family physician are crucial for managing the complex health needs of persons with dementia. Objective To provide a comprehensive overview of primary care use among community-dwelling persons with dementia in Quebec from 2018 to 2020.

Primary Care 130

Primary Care Community Family Physician Diagnosis 130

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § EKRA Issue.

Lab Testing 52

Lab Testing Individual Referral Patient-Centered 52

PEMBlog

APRIL 20, 2023

Cristina Tarango, director of the Hemophilia Treatment Center at Cincinnati Children’s and Lisa Littner, Project Manager at Cincinnati Children’s who helped me research and write this post. Emicizumab (Hemlibra) was approved in 2018 for routine bleeding prophylaxis in hemophilia A with or without inhibitors.

Individual 52

Individual Patient-Centered Patients IT 52

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § EKRA Issue.

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

FDA Law Blog

SEPTEMBER 20, 2021

FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

Physician's Weekly

JUNE 19, 2025

“It’s also often the family member or the person helping to manage them.” The Health Resources and Services Administration projects a 50% increase in demand for geriatricians from 2018 to 2030, when the entire baby boom generation will be older than 65. ” In 27 states and Washington, D.C.,

Nurse Practitioner 52

Nurse Practitioner Families Family Primary Care 52

Physician's Weekly

JUNE 22, 2025

Similarly, listening was rated lower (β = −0.286, 95% CI = −0.391 to −0.181, P = 0.001), as were explanations provided by clinicians (β = −0.133, 95% CI = −0.267 to −0.000, P = 0.050). These included how well physicians demonstrated respect, listened to individuals, explained information, and spent enough time with them.

Individual 59

Individual Insurance Education Medical 59

Physician's Weekly

JUNE 11, 2025

The systematic review of peer-reviewed intervention was published from 2018 to 2023. An Outside Expert Shares Her Perspective Nadine Harris, MD , who was not involved in the study, spoke with Physician’s Weekly ( PW ) about the results and ways to provide optimal care to Black women with HIV.

Mental Health 114

Mental Health Healthcare Professional Community Healthcare 114

GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. And yet, after assisting the older adult to their feet, the EMS providers would leave. I think, as providers, we don’t get to see that.

Community 114

Community Transportation IT PCP 114

FDA Law Blog

OCTOBER 17, 2023

FDA previously released the final guidance document in December 2018 outlining the program’s principles, features, designation criteria, and other considerations. Additionally, the 2022 draft guidance suggested the addition of a new section to the 2018 guidance on reducing disparities in health and healthcare.

Medical 53

Medical Diagnosis Healthcare Clinic 53

GeriPal

MARCH 2, 2023

2022 Perioperative Gabapentin Use in Older AdultsRevisiting Multimodal Pain Management JAMA IM. JAMA Surgery 2018 Gabapentin and mood stabilizers in the Nursing Home Setting: Antiepileptic prescribing to persons living with dementia residing in nursing homes: A tale of two indications. J Am Geriatr Soc.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

The Clinical Problem Solvers

MAY 30, 2022

Kozhimannil—the Distinguished McKnight University Professor in the Division of Health Policy and Management at the University of Minnesota and Director of the Rural Health Research Center. As healthcare providers, we must listen to our patients and use the power of our presence to see birthing people’s full humanity and empowerment.

Community 52

Community Patient-Centered Families Family 52

GeriPal

JULY 21, 2022

Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. So that’s a piece that I think is important for providers anywhere along that process to be asking about driving. And the primary care provider had assumed he was no longer driving, I think. Emmy: Yeah. Emmy: Yeah.

IT 102

IT Families Family Diagnosis 102

FDA Law Blog

MAY 16, 2024

UMHS agreed to resolve the allegations in August 2018 for $4,300,000 and compliance with a three-year Memorandum of Agreement (“MOA”). Controlled substances are a necessary component in hospitals providing needed medical care to patients. The nurse who allegedly stole the drugs died in March 2022.

Hospital 59

Hospital Patient-Centered Medical Provider 59

GeriPal

OCTOBER 24, 2024

If you believe the evidence for efficacy to manage symptoms like neuropathic pain, how do you even start to think about recommending these products to patients? And then in 2018, when adult use was allowed in California, I think it gave people more permission, but the stigma is still there. It was really, really impressive to me.

Medical 98

Medical IT Patient-Centered Healthcare 98

GeriPal

APRIL 3, 2025

We covered: The first parody song I wrote, for AGS 2018 in Orlando , about this article by Nancy Schoenborn on how to discuss stopping cancer screening. Alex joined in 2018. This was 2018 in AGS Orlando, and they did a song about when to stop screening for cancer for colon cancer. Alex 05:15 Oh, really? And so we did this song.

IT 64

IT Hospital Screening Patients 64

GeriPal

JUNE 22, 2023

Michele: Yeah, so in May of 2018, there was an article by Suleika Jaouad in the New York Times Magazine, and they spent about two weeks in our hospice with us learning about the work that’s done. Michele: The article was 2018, but I think Bonnie read the article more recently. Eric: How long ago was this? Alex: A few years back.

Families 132

Families Family IT Community 132

GeriPal

MARCH 3, 2022

I want to say like 2017, 2018, something like that. And then when I did residency in internal medicine first, there was just a lot of focus on a lot of heroic management in the ICU that didn’t always appeal to me without thinking about what the morbidity might look like. It was amazing. It was really, really crazy. Alex: Yeah.

Patient-Centered 96

Patient-Centered Patients IT Hospital 96