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. Yet this expansion has come with a significant administrative burden, particularly that of clinical documentation.

Patient-Centered 52

Patient-Centered Telemedicine Clinic Electronics 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. Study Design: This retrospective case series analysis utilizes Vizient’s clinical database data. Mixed models were used for analysis. Setting: AMCs within the US.

Utilities 130

Utilities Healthcare Patient-Centered Illness 130

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. Watchful waiting refers to clinical observation only. A recent analysis of the U.S.

Routine Screenings 52

Routine Screenings Screening Complication Diagnose 52

The Clinical Problem Solvers

OCTOBER 18, 2022

Our guests remind us to think critically about our role in the carceral system and in imposing systems of control and punishment within clinical settings. Providing communities with the resources they need to survive, such as educational opportunities, jobs, and quality healthcare, will eliminate the need for incarceration.

Healthcare Professional 52

Healthcare Professional Healthcare Patient-Centered Mental Health 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.

Manufacturing 115

Manufacturing IT Provider ER 115

FDA Law Blog

OCTOBER 2, 2023

The eagerly anticipated guidance, Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence (i.e., Instead, FDA’s determination of whether a single study plus confirmatory evidence could provide substantial evidence is to be “based on relevant science.”

IT 64

IT Clinic Provider Medical 64

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.

Clinic 98

Clinic Provider IT Patients 98

FDA Law Blog

SEPTEMBER 30, 2022

Billy Dunn, the Director of CDER’s Office of Neuroscience, at the September 7, 2022 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee, applying the statutory standard in approval decisions in these clinical contexts warrants the “broadest possible” flexibility. By Frank J. Sasinowski & James E.

Community 98

Community Provider Patients Specialization 98

FDA Law Blog

MAY 13, 2024

FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”

Medical 111

Medical Clinic Patients IT 111

The Clinical Problem Solvers

SEPTEMBER 19, 2024

Describe the positive impacts of qualitative methods on healthcare provision and/or policies in clinical settings. 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.

Internal Medicine 52

Internal Medicine Patient-Centered Specialization Community 52

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. Interpretation of Statutory Criteria Under the Final Guidance. Medical information about a patient.

Clinic 52

Clinic Medical Provider Patients 52

CDOCS

MARCH 15, 2021

Patients depend on our clinical knowledge as well as our recommendations and relationships with our specialist partners.</span></span></p> Nelson further explains, &ldquo;I believe a key component to success for case acceptance is providing education to my staff and the offices I work with.

Patients 52

Patients Finance Education Utilities 52

FDA Law Blog

FEBRUARY 28, 2022

The Agency’s goal is demonstrated in its definition of patient engagement: “Patient engagement is defined as intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” .

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law Blog

OCTOBER 11, 2022

For the past two years, CDER’s Guidance Agenda has included a spot for this eagerly anticipated guidance, tentatively titled ‘Meeting the Substantial Evidence Standard Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence’. Sasinowski & James E.

Clinic 61

Clinic Provider IT Patient-Centered 61

PEMBlog

MARCH 4, 2025

Well cover its clinical presentation, epidemiology, diagnostic approach, and management, including why standard beta-lactam antibiotics wont work. Learning Objectives Describe the clinical presentation, epidemiology, and complications of Mycoplasma pneumoniae infections in pediatric patients, including its atypical manifestations.

Patient-Centered 91

Patient-Centered Diagnosis Complication Community 91

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

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

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. The Journal of Clinical Psychiatry. As Nicholas et al. Nicholas DB, Muskat B, Zwaigenbaum L, et al.

Family 77

Family Families Patient-Centered Physicals 77

FDA Law Blog

OCTOBER 14, 2021

Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes. It is well out of bounds for FDA to regulate them as if they were a determinant of long term clinical outcomes. In this safety communication, FDA states: The U.S. The question answers itself.

Patient-Centered 52

Patient-Centered Healthcare Manufacturing Provider 52

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.

Medical 64

Medical Electronics Manufacturing Utilities 64

FDA Law Blog

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.” 21 U.S.C. § 355(i)(1)(A). 42 U.S.C. §

Clinic 64

Clinic IT Utilities Government 64

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

JUNE 29, 2022

The Expedited Programs Guidance describes situations warranting rescission as when emerging data no longer support the BTD, another product gains traditional approval and evidence is not provided that the designated drug may demonstrate substantial approval over the approved product, or when the program is no longer being pursued.

IT 52

IT Clinic Provider Medical 52

FDA Law Blog

JULY 10, 2023

By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Philip Won & Adrienne R. But that is only the beginning.

Provider 75

Provider IT Engineering Medical 75

FDA Law Blog

JUNE 23, 2021

I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. What Dr. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.

Patients 52

Patients Patient-Centered Clinic IT 52

PEMBlog

SEPTEMBER 27, 2023

The diagnosis of a virus illness is generally made clinically with a history and clinical exam and does not require confirmatory testing. A negative test can also provide false reassurance. The clinical utility of respiratory viral testing in hospitalized children: a meta-analysis. for bronchiolitis and 1.5% JAMA Pediatr.

Patients 52

Patients Illness Hospital Management 52

FDA Law Blog

MARCH 1, 2023

By way of background, FDA first proposed using a QMM rating in its 2019 Report on Drug Shortages and Potential Solutions. The report recommends using a QMM rating that is shared throughout the market (purchasers, consumers, competing manufacturers) to provide manufacturers committed to QMM with a competitive advantage. By Holly N.

Management 45

Management Manufacturing Supply Chain Provider 45

FDA Law Blog

SEPTEMBER 15, 2022

Interestingly, in the 2019 proposal for sunscreen labeling, FDA proposed to require a size at least one quarter the size of the most prominent printed matter). Interestingly, it provides information for manufacturers who want to include (voluntarily) the phosphorus level in the drug product. regarding the statement of identity.

Manufacturing 45

Manufacturing Hypertension IT Provider 45

FDA Law Blog

JANUARY 6, 2022

In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. §

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 52

FDA Law Blog

SEPTEMBER 29, 2021

Department of Health and Human Services (“HHS”), which reported that discounted purchases totaled $38 billion in 2020, a 27% increase compared to 2019. In fact, the Advisory Opinion was the first agency document to explicitly conclude that manufacturers are required by statute to provide 340B drugs to multiple contract pharmacies.

Manufacturing 52

Manufacturing Government Referral Provider 52

Physician's Practice

JUNE 25, 2025

These videos are 5 to 10 minutes in length and will provide practical ideas and suggestions that have been tested in his practice or used by other physicians that significantly improve the efficiency and productivity of their medical practices. Dr. Baum is Professor of Clinical Urology at Tulane Medical School in New Orleans, Louisiana.

Patients 52

Patients Private Practice Management Healthcare 52

FDA Law Blog

MAY 17, 2022

But in May 2019, FDA approved a second amifampridine drug product, Jacobus Pharmaceutical Company, Inc.’s And UFA reauthorization provides the perfect vehicle for the Agency to try and get this accomplished. Usually FDA’s lobbying activities are done rather quietly. Usually FDA’s lobbying activities are done rather quietly.

IT 40

IT Patients Individual Provider 40

FDA Law Blog

JANUARY 6, 2022

In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. §

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

Annals of Family Medicine

NOVEMBER 20, 2024

A US-based study conducted by the Kaiser Family Foundation found 69% of patients reported avoiding discussions about death, but 92% reported feeling somewhat comfortable talking to a heath care provider about EOL wishes. Setting or Dataset: Outpatient palliative care cancer clinic at a tertiary health care center in the U.S.

Patients 130

Patients Patient-Centered Provider Education 130

FDA Law Blog

JUNE 7, 2021

Subpart H) pathway in 2014, then issued it as final guidance in January 2019. However, the FDA guidance goes on to say in some cases, additional context is needed by specifically inserting a sentence in the indications statement that: no clinical benefit has been established. This has been a decision we’ve been closely following.

Clinic 98

Clinic IT Private Practice Utilities 98

GeriPal

MARCH 24, 2023

For others, this piece, while painful to read, gave voice to what they have been feeling over the last decade – hospice has in some ways lost its way in a quest of promoting profit over care. If you are interested in signing the position statement “Core Roles and Responsibilities of Physicians in Hospice Care”, click here. Is it you, Ira?

IT 115

IT Provider Patients Families 115

The Clinical Problem Solvers

DECEMBER 20, 2021

Highlight how structural racism against Asian-Americans surfaces in clinical settings, and describe means of counteracting such structures. Remember that more deeply understanding your patients can provide meaning! Insufficient language services (i.e., provision in only English +/- Spanish), limitations of medical technology (i.e.,

Community 52

Community Patient-Centered Relationship Healthcare 52