StorytellERdoc

MARCH 1, 2019

Especially the kids, who often had matching fleece blankets, I enjoyed the style of these pajamas and the apparent comfort they seemed to provide. People will stare. Make it worth their while. Can someone please tell me the exact moment when fleece pajama bottoms became the fashion sensibility of America? Little Pony is my favorite!"

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ER Families Family IT 100

The Medical Futurist

JUNE 17, 2025

Researchers in 2019 developed a machine learning method to accurately quantify immune cells in the vicinity of oral cancer cells. Smart toothbrush While AI helps dental professionals provide better treatments, smart toothbrushes enable all of us to take better care of our teeth.

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Patients Treatment Plan Healthcare Medical Specialty 126

FDA Law Blog

APRIL 8, 2025

DPD met all of the GDUFA commitments to publish policy documents (Section IX of the GDUFA III Commitment Letter ) and published many others the Division determined would provide clarity to the generic drug industry. Providing significant policy support to the annual update of the Orange Book Preface. 314.150(c).

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IT Manufacturing Provider Management 144

FDA Law Blog

OCTOBER 27, 2024

The next step in this shift of policy was FDA’s withdrawal in late 2019 of its 1998 Compliance Policy Guide (“CPG”) 400.400, discussed here. The genesis of this lawsuit is a disagreement over regulatory language and, more significantly perhaps, statutory interpretation. Maybe you recall the viral blue dress/yellow dress internet sensation.

IT 100

IT Community Provider Illness 100

Annals of Family Medicine

NOVEMBER 20, 2024

2019/pre-pandemic and 2020/pandemic cohorts included 167,095 vs. 173,240 PLWD living in the community and 93,374 vs. 92,434 PLWD residing in nursing homes (NHs), respectively. Analysis: We compared 2020 to 2019 in 3 periods (1st wave; interim period; 2nd wave) and conducted meta-analyses on the provincial estimates.

Healthcare 130

Healthcare Community Hospital Management 130

Physician's Weekly

JUNE 19, 2025

This study uncovered negative and positive provider, treatment, and system-related factors that contribute to these patients’ experiences and offered recommendations for improving care experiences.” Provide printed “What to Expect” one‑pagers at registration to align patient expectations with ED capabilities. Clarify ED scope.

Mental Health 52

Mental Health Physicals Patient-Centered Patients 52

Annals of Family Medicine

NOVEMBER 20, 2024

Objective: To assess the epidemiology and mortality risk among patients discharged from AMCs General Medicine Service Lines in the US from Oct 2019 to Dec 2023. The study is divided into three periods: pre-COVID (Oct 2019 to Mar 2020), COVID (Apr 2020 to May 2023), and postCOVID (Jun 2023 to Dec 2023). Setting: AMCs within the US.

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Utilities Healthcare Patient-Centered Illness 130

Plum Health

JULY 6, 2023

Studies conducted by the Society of Actuaries (SOA) and Milliman provide valuable insights into these new models of healthcare delivery and financing. DPC and Subscription-based Primary Care are healthcare delivery models where a provider offers unlimited specified routine healthcare services for a monthly fee. As of 2019, 49.6%

Primary Care 52

Primary Care Healthcare Insurance Finance 52

Minnesota Academy of Family Physicians

MAY 6, 2025

The MAFP is in support of these bills and any effort to bridge the language gap between patients and health care providers. Resolution 2019-17A : Monitoring and evaluating legislation related to interpreter training, access and quality standards.

Family Physician 52

Family Physician Primary Care Telehealth Community 52

Common Sense Family Doctor

DECEMBER 14, 2024

in 2019, with 78% receiving radiation therapy and 22% undergoing surgery. A 2019 AFP editorial provided more guidance for estimating and having conversations about life expectancy with older patients. ** This post first appeared on the AFP Community Blog. Watchful waiting refers to clinical observation only. in 2000 to 59.8%

Routine Screenings 52

Routine Screenings Screening Complication Diagnose 52

FDA Law Blog

JANUARY 15, 2024

If you made it through the first 2 pages of the opinion, this Court’s answer is clear: FDA flagrantly violated the APA in denying those flavored e-cigarette applications due to the Agency’s utter failure to provide comprehensible instructions and consistent policies. FDA also directed manufacturers to produce detailed marketing plans.

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Manufacturing IT Provider ER 115

Annals of Family Medicine

NOVEMBER 20, 2024

Intervention/Instrument: Eligible participants with ARIs provided demographic, epidemiologic, and symptom data, along with a nasal swab or oropharyngeal specimen. Conclusion: Since its emergence in 2020, SARS-CoV-2 was detected year-round and with a higher median age than other pathogens.

Community 130

Community Families Family Provider 130

Physician's Weekly

JUNE 24, 2025

We need to ensure efficient throughput to allow us to provide access to as many patients as we can,” said David Schnadower, MD, MPH, of Cincinnati Children’s Hospital Medical Center in a news release. “An Pediatric emergency departments can get crowded quite quickly, especially during winter infection season.

Patient-Centered 52

Patient-Centered Families Family Hospital 52

FDA Law Blog

OCTOBER 2, 2023

A brief explainer on confirmatory evidence: how we got here Before we dive into the specifics of the new guidance, we should explain that the statutory standard we allude to is the requirement that an applicant provide “substantial evidence of effectiveness” to obtain approval of an NDA or BLA.

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IT Clinic Provider Medical 64

The Clinical Problem Solvers

OCTOBER 18, 2022

Providing communities with the resources they need to survive, such as educational opportunities, jobs, and quality healthcare, will eliminate the need for incarceration. The ways to remedy the negative impacts of incarceration are to incarcerate fewer people and to invest in communities.

Healthcare Professional 52

Healthcare Professional Healthcare Patient-Centered Mental Health 52

Today's Hospitalist

MAY 9, 2025

Since the mid-1990s, our capacity for innovation has never stopped as hospitalists navigate a complex landscape of acute illnesses, interprofessional collaborations and the imperative to provide efficient, high-quality care. We have seen explosive growth and become a cornerstone of modern health care systems.

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Patient-Centered Telemedicine Clinic Electronics 52

FDA Law Blog

SEPTEMBER 30, 2022

These remarks by Dr. Dunn and his Summary Review offer insights into the practical application of the FDA’s December 2019 draft guidance on substantial evidence of effectiveness (as we will discuss further below). By Frank J. Sasinowski & James E. Hyman, Phelps & McNamara, P.C.’s

Community 98

Community Provider Patients Specialization 98

FDA Law Blog

MAY 31, 2023

On May 24, 2019, Morris & Dickson paid a $22 million civil penalty related to the failure to report suspicious orders and ignoring certain red flags in the distribution of controlled substances. Neither the CSA nor regulations promulgated by DEA provide any deadline for issuing a Final Order and Decision.

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IT Government Provider 59

Aspiring Minority Doctor

MARCH 14, 2022

My two years spent working as an urgent care physician allowed me to become comfortable managing acute issues on my own, gave me the freedom to enjoy life on my own terms, and provided the financial means to apply to as many surgery programs as possible during my third application cycle. I actually failed to match twice! It isn’t over yet.

Medical Student 52

Medical Student Medical Management IT 52

Myriad Genetics

MAY 20, 2025

It’s encouraging to see patients recognize what we, as healthcare providers, already know—that medications can be an effective option for people struggling with depression, anxiety, and other mental health conditions,” said Dr. Brown. He was elected to serve AAPOR as its Vice President, President, and Past President from 2011-2014.

Mental Health 52

Mental Health Diagnose Medical Patients 52

FDA Law Blog

AUGUST 12, 2021

As a result of this decision, Semglee can now be substituted for Lantus prescriptions without the intervention of a health care provider in accordance with state substitution regulations. Thus, though Semglee is not new to the market, it is for the first time substitutable for Lantus without intervention of a health care provider.

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Clinic Provider IT Patients 98

FDA Law Blog

SEPTEMBER 23, 2024

(Thanks to the Ronald Reagan Presidential Library & Museum and its White House Photo Collection Contact Sheets, you can see some of the enactment pictures here and here with President Reagan, Margaret Heckler, Strom Thurmond, Orrin Hatch, Henry Waxman, James (Jimmy) Quillen, and Ralph Regula.) Is it over the hill? (Or

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Provider IT 59

FDA Law Blog

MAY 13, 2024

Rather than looking at how RWD/RWE provide meaningful information on safety and effectiveness, reviewers often focus on perceived gaps. However, based on our experience reviewing device premarket submissions and engaging with FDA, we have found that reviewers have not embraced it in practice.

Medical 111

Medical Clinic Patients IT 111

CDOCS

MARCH 15, 2021

’ When working with a case that requires a combination of expertise from the general dentist and specialist, it is our job to be able to explain and provide understanding on all aspects of treatment. link] Dated June 2019. & To us it seems simple; we work with our colleagues on a daily basis.&

Patients 52

Patients Finance Education Utilities 52

The Clinical Problem Solvers

SEPTEMBER 19, 2024

Interconception Care for Primary Care Providers: Consensus Recommendations on Preconception and Postpartum Management of Reproductive-Age Patients With Medical Comorbidities. During this episode, we hear from Dr. S. Zakaria, S., Vaught, A. Toth-Manikowski, S. M., & Smith, G. Gutterman, S., & Ubel, P. link] Sloan, C.

Internal Medicine 52

Internal Medicine Patient-Centered Specialization Community 52

FDA Law Blog

OCTOBER 11, 2022

Additional guidance on confirmatory evidence is sorely needed as the December 2019 draft guidance spends just two of its 18 pages telling us what FDA thinks of such a key piece of statutory language. Since 1962, the Act has given FDA authority to reject a drug application that fails to provide substantial evidence of effectiveness.

Clinic 61

Clinic Provider IT Patient-Centered 61

FDA Law Blog

AUGUST 9, 2021

As you may remember, Genus sued FDA back in 2019, alleging that FDA’s classification of, and putative regulation of, its barium sulfate products as drug products violated the FDCA because barium sulfate meets the statutory definition of medical device and therefore must be regulated as a device.

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IT Medical Complication Provider 52

FDA Law Blog

JUNE 15, 2022

billion annually, and continued the same reimbursement cuts for 2019. In 2019, we blogged that the District Court found for the plaintiffs, holding that CMS did not have the statutory authority to make such a change without first conducting a hospital acquisition cost survey data. CMS estimated a savings of $1.6 Becerra, No.

Hospital 52

Hospital Government Provider IT 52

FDA Law Blog

MAY 8, 2023

See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g., here for a 510(k) device and here for a PMA device). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law Blog

NOVEMBER 7, 2024

Provided that a brief device description, clear intended use, and list or picture of all labeling claims are made, FDA aims to review the information and provide a response generally within 7 days. By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N.

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Provider IT Consulting Utilities 69

FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. The guidance provides no rationale for hinging the device status of CDS software on the frequency with which medical information is collected.

Clinic 52

Clinic Medical Provider Patients 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. 2019-1895L. Create quick-access resources (digital or physical) in high-traffic care areas. As Nicholas et al. Pediatrics.

Family 80

Family Families Patient-Centered Physicals 80

The Clinical Problem Solvers

APRIL 3, 2023

He mentions that healthcare was provided to Indigenous peoples rooted in a charitable effort, rather than as a basic human right. The dehumanization of individuals of color at the margins of society by the healthcare system is not simply a thing of the past, and is certainly a persistent phenomenon.

Medical 52

Medical Healthcare Individual Community 52

FDA Law Blog

OCTOBER 17, 2021

As part of the process of moving from the old rule-based monograph system to an administrative order framework, the CARES Act provides that in most cases a final monograph or tentative final monograph that establishes conditions of use for a drug described in section 505G(a)(1) or (2) of the FD&C Act is “deemed to be a final order”.

Provider 52

Provider IT Healthcare Patients 52

PEMBlog

MARCH 4, 2025

Clin Infect Dis 2019; 68:13. In this episode we dive into the resurgence of Mycoplasma pneumoniae an atypical bacterial cause of community-acquired pneumonia thats making waves in pediatric emergency medicine. Plus, well discuss whether M. pneumoniae even needs to be treated in the first place! Plus, well discuss whether M. Epub 2024 Aug 3.

Patient-Centered 93

Patient-Centered Diagnosis Complication Community 93

FDA Law Blog

SEPTEMBER 11, 2023

More recently, in 2019, FDA announced a push for predicate modernization ( link ) following a 2018 plan to modernize the 510(k) program by eliminating use of old predicates, sunsetting older predicates, and establishing the Safety and Performance Based Pathway ( link ). Baumhardt, Senior Medical Device Regulation Expert & Adrienne R.

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Medical Electronics Manufacturing Utilities 64

FDA Law Blog

NOVEMBER 6, 2022

In June 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Now, after an unfavorable HHS Office of the Inspector General (OIG) advisory opinion and two defeats in court, Pfizer has appealed the Second Circuit’s decision to the Supreme Court. Background.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83