Annals of Family Medicine

NOVEMBER 20, 2024

Context: Providing critical care for people living with dementia (PLWD) during the COVID-19 pandemic outbreak was raised as a global concern. Step 1: Compared rates of ICU admissions in three 2020 periods (1st wave; interim period; 2nd wave) to the corresponding 2019 periods. Analysis: We used a 2-step meta-analytical approach.

Community 130

Community Individual Hospital Provider 130

OCFM

OCTOBER 23, 2020

October 23, 2020 / Jack Forbush, DO / News Jack Forbush, DO Helpful video out together by one. Notice of Privacy Policy

Family Medicine 52

Family Medicine DO Primary Care Patient-Centered 52

Annals of Family Medicine

NOVEMBER 20, 2024

Objective: This project explored the presence, nature, and effects of moral distress in Canadian primary healthcare professionals from two provinces during (March 2020-May 2023) and after the COVID-19 pandemic. Intervention/Instrument: Individual semi-structured interviews and review of pertinent case-relevant documents.

Primary Care 130

Primary Care Healthcare Professional Family Medicine DO 130

Annals of Family Medicine

NOVEMBER 20, 2024

Context: Family physician (FP) scope of practice (SOP) has declined, with fewer physicians providing basic primary care services and fewer bridging the clinic-hospital divide. Population Studied: 5,006 US family medicine residency graduates from 2017 to 2020 with 58% females, 39% aged 35 or older, and 85% practicing in urban areas.

Family Physician 130

Family Physician Families Family Finance 130

Annals of Family Medicine

NOVEMBER 20, 2024

In 2020 and 2021, CDC guidelines changed recommended treatment for both GC and CT. Population Studied: Individuals with gonorrhea and chlamydia positive tests. Objective: This study evaluates incidence of CT and GC, treatment associated outcomes, and adherence to guideline changes. in an urgent care setting.

Healthcare 130

Healthcare Primary Care Hospital Diagnose 130

Common Sense Family Doctor

FEBRUARY 28, 2025

Meanwhile, the estimated time needed to provide guideline-recommended preventive care, chronic disease care, and acute care to a nationally representative panel of 2,500 adult patients is an impossible 26.7 Since 2020, the starting ages for breast, lung, and colorectal cancer screening were lowered to 40, 50, and 45 years, respectively.

Primary Care 52

Primary Care Family Physician Preventive Care Preventative Care 52

OCFM

DECEMBER 7, 2020

White.well deserved December 07, 2020 / Jack Forbush, DO Cherryville’s White is N.C.’s Notice of Privacy Policy

Family Medicine 40

Family Medicine DO Primary Care Patient-Centered 40

BMJ

JULY 17, 2020

A multilayered view of stigmatizing discourses lays the foundation for eliciting a series of suggestions for quelling stigma, to be implemented at the individual, community, and national levels, as suggested by the WHO. Int J Soc Psychiatry 2020 (May 21; published online). Front Commun ́2020 (June 12; published online).

Community 40

Community Individual Physicals Finance 40

BMJ

AUGUST 20, 2021

doi: 10.1136/fmch-2020-000845 The appetite for and ability to collect accurate digital patient-level data in low-resource settings has fueled numerous massive global health initiatives. As impressive as these large numbers may be, the question that is less often asked is “How much of that big data is actually helping us do better?”

Patient-Centered 40

Patient-Centered Clinic Provider Patients 40

The Clinical Problem Solvers

APRIL 3, 2023

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. Cindy Gladue, Brian Sinclair, and Joyce Echaquan are three Indigenous individuals who suffered immense harm at the hands of the healthcare system.

Medical 52

Medical Healthcare Individual Community 52

FDA Law Blog

AUGUST 23, 2022

After two negative tests, you should consider a molecular test, or call your healthcare provider. If the third test is negative, you should test again with an antigen test, or get a laboratory molecular-based test, or call your healthcare provider. If the second test is negative, you should test again 48 hours after the second test.

Individual 97

Individual Clinic Healthcare Provider 97

The Clinical Problem Solvers

DECEMBER 16, 2020

Moreover, center patients not only in discussions about individual decision-making but in constructing and drawing meaning from the research. September 8, 2020. Published online May 11, 2020. Published online July 29, 2020. Published online July 29, 2020. Published July 2, 2020. 2016 Jul;91(7):916-20.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

DECEMBER 7, 2022

In simple terms from a non-scientist, these gene therapies add functional versions of genes to patients that do not have them, and thus the idea is to have these genes function in the same way as they do in individuals without these disorders.

Clinic 119

Clinic Patients IT Provider 119

FDA Law Blog

SEPTEMBER 19, 2023

Thus, “FTC intends to use its full legal authority” to take action “against companies and individuals that improperly list patents in the Orange Book that do not meet the statutory listing criteria.” And FDA did not provide a substantive response to 5 Requests for Advisory Opinions seeking clarification of the issue.

Manufacturing 105

Manufacturing Provider IT Healthcare 105

FDA Law Blog

OCTOBER 13, 2024

Designed to incentivize the development of drugs for pediatric rare diseases where such development may not otherwise have occurred, vouchers may be granted for drugs for serious or life-threatening rare diseases where the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years.

Government 64

Government IT Education Individual 64

GeriPal

AUGUST 4, 2022

My take home from this is that while the most preferred explanation for deprescribing statins and sedative-hypnotics is one focused on the risk of side effects, we also need to individualize it to the patient and the medication that they are taking. Maybe that’s where the individualizing it, the person that’s front of me.

Specialization 104

Specialization Medical Patient-Centered Provider 104

FDA Law Blog

OCTOBER 9, 2023

The ACA sets an annual cap on the amount that insurers can require insured individuals to pay out of pocket for their medical expenses. The ACA sets an annual cap on the amount that insurers can require insured individuals to pay out of pocket for their medical expenses. Gaulkin & Jeffrey N. Wasserstein — The U.S.

Insurance 40

Insurance Manufacturing Patient-Centered Individual 40

FDA Law Blog

FEBRUARY 23, 2025

To help in evaluating device changes, manufacturers commonly refer to FDAs guidance Deciding When to Submit a 510(k) for a Change to an Existing Device, which provides FDAs interpretation of the changes it believes could significantly affect the safety or effectiveness of a device. Notably, FDAs public WL database only goes back to 2020.

Manufacturing 64

Manufacturing Provider Consulting IT 64

FDA Law Blog

NOVEMBER 14, 2022

The draft guidance provides information regarding various aspects of the OMUFA program under sections 744L and 744M of the FDC Act, as added by the CARES Act. FDA stresses that the law does not provide exemptions or waivers. By Riëtte van Laack & Deborah L. Livornese — Early Nov.

Manufacturing 52

Manufacturing Individual Management Provider 52

FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

JANUARY 2, 2025

The proposed revised rule constituted a radical change from the original definition of healthy, which focused on the presence of individual (beneficial) nutrients. In contrast, the 2022 proposed redefinition focused on food groups recommended by nutrition science and the Dietary Guidelines (DGs), 2020-2025.

Individual 52

Individual Manufacturing Provider IT 52

FDA Law Blog

MAY 8, 2023

In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications. Performance evaluation protocols : The MP should include plans to verify and validate modifications.

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law Blog

OCTOBER 5, 2022

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. It is focused on the nutrients in the food product rather than on it overall nutritional “quality.”.

Provider 52

Provider Individual IT Manufacturing 52

ABIM

APRIL 24, 2025

Dave, MD, MPH , inquired how stressors may contribute to candidates failing the certification examination and Dr. McDonald stated that knowledge gaps were the primary cause, though ABIM provides safeguards to reduce stress like grace periods and consideration of compassionate exemptions for extraordinary life circumstances.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

33 Charts

OCTOBER 2, 2021

According to Epic, the number of patient messages spiked 151 percent nationally from the period covering the first 11 weeks of 2020 through the end of the year. Inconsistency in care delivery So as every provider shapes her practice around MyChart, each will do it in a slightly different way. And individual practice styles are fine.

Patients 75

Patients IT Provider Family Doctor 75

FDA Law Blog

MAY 4, 2023

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ).

Clinic 59

Clinic Telehealth Provider Electronics 59

FDA Law Blog

FEBRUARY 27, 2024

For years after the enactment of the Hatch-Waxman Amendments the PTO interpreted the PTE statute to permit multiple PTEs, provided there are separate, but not necessarily different, regulatory review periods. FDA-2020-E-1840 (July 13, 2020). FDA-2020-E-1840 (Mar. 2020) , has not yet—and to our surprise—ended up in court.

Patients 59

Patients IT Provider Individual 59

FDA Law Blog

NOVEMBER 6, 2022

Rather, Pfizer argues, the AKS focuses on “corrupt transactions,” such as the specific examples of “kickback, bribe, or rebate” that Congress provided. The Medicare program would pay most of the remaining $225,000 in annual cost.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

Annals of Family Medicine

NOVEMBER 20, 2024

Objective To provide a comprehensive overview of primary care use among community-dwelling persons with dementia in Quebec from 2018 to 2020. Population Studied Community-dwelling persons aged 65 and older with a prevalent diagnosis of dementia on March 1st of 2018, 2019, and 2020. 60.8%, 60.2%, and 58.8%

Primary Care 130

Primary Care Community Family Physician Diagnosis 130

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 Day 90 FDA sends final MDUFA Decision on 510(k).

Provider 75

Provider IT Engineering Medical 75

FDA Law Blog

JULY 4, 2023

The CARES Act also provides for an administrative hearing process that may be utilized under certain conditions following the formal dispute resolution process. FDA will determine the total number of individuals who can attend the consolidated proceedings in person. This is the third topic included in the new draft guidance.

Utilities 52

Utilities Provider Individual IT 52

FDA Law Blog

MARCH 4, 2024

The draft guidance provides recommendations for applicants and manufacturers about the requirements for notifications about production changes of certain finished drugs and biological products and certain active pharmaceutical ingredients (API), and outlines information FDA would like to receive in addition to the requirements.

Manufacturing 59

Manufacturing Supply Chain Provider Treatment Plan 59

PEMBlog

OCTOBER 18, 2024

Emergency Care Plans and Advanced Directives Many DMD patients will arrive with comprehensive emergency care plans or letters from their providers. 2020 Jun 5;15(1):141. DMD patients often receive yearly MRIs to monitor their cardiac health, as discrepancies between MRI and echo findings are common. Orphanet J Rare Dis.

Patients 52

Patients Complication Management Consulting 52

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

DECEMBER 13, 2023

Dr. Janet Maynard, Director of this Office, highlighted in the press release that “[g]enetic metabolic diseases include very rare diseases that individually affect a limited number of patients. Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.”

Patient-Centered 59

Patient-Centered Medical Patients IT 59

FDA Law Blog

JUNE 23, 2021

For example, we know that cancer patients have a high tolerance for toxicity when offered a chance at improved survival, a risk tolerance that would not be shared by individuals suffering from the common cold. However, in the coming days we hope to do so and may provide our thoughts in subsequent posts.

Patients 52

Patients Patient-Centered Clinic IT 52

FDA Law Blog

JUNE 22, 2023

Regarding COVID-19, Tim Stenzel, Director of CDRH’s Office of In Vitro Diagnostics, has stated that “in-home testing and home collections is a top priority” ( June 2020 FDA Virtual Town Hall ); “obviously home over-the-counter tests including rapid antigen tests are a high priority” ( February 2021 FDA Virtual Town Hall ). seeking treatment).

Manufacturing 59

Manufacturing Clinic IT Transportation 59