SQA

MARCH 25, 2021

The concepts presented in PDA Technical Report No. United States Food and Drug Administration (FDA) – Regulations and Guidances for Biologics and the Bioresearch Monitoring Program (BIMO). Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing SARS-CoV-2 Virus Variants, 22 February 2021.

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SQA

JUNE 10, 2021

ANVISA released on 05 March the report Regulation in Numbers , presenting the 2020 actions aiming to improve the regulatory quality of the Agency. FDA plant inspection and pay $50 million in fines and forfeiture. ANVISA: The Advances of 2020 in Regulatory Quality Improvement, 31 March 2021.

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FDA COVID-19 COVID-19 Vaccine Compliance 52

Bill of Health

SEPTEMBER 29, 2022

In the July 29, 2022 notice, the USPTO set forth its views on the “duty of disclosure” and “duty of reasonable inquiry,” emphasizing the importance of consistency between statements made to the USPTO, the FDA, and other governmental agencies. Background Context.

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SQA

FEBRUARY 15, 2023

Eudralex, Volume 4: GMP Guidelines and Annexes Revision of the EU GMP Guide Annex 11 “Computerized Systems” – Presentation of Concept Paper, 18 November 2022 On 16 November 2022, the European Medicines Agency EMA published a concept paper on the planned revision of Annex 11 “Computerized Systems.”

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Healthcare Law Blog

AUGUST 9, 2023

8] The court in Members of the Medical Licensing Board of Indiana, et al. 20 will take effect, including: requirements for all surgical abortions to take place in hospitals; licensing requirements for abortion clinics; expanded practice authority for certified nurse midwives; and new provisions for the “safe surrender” of an infant. [22]

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Health Law Advisor

MARCH 1, 2023

On February 14, 2023, the Utah Senate passed a bill that would repeal the State’s “Online Prescribing, Dispensing, and Facilitation Licensing Act” (“Online Prescribing Act”). 2] Statements of Charges may be found on the Washington State Department of Health website, filed under the individual provider’s name and/or license number.

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Telemedicine COVID-19 Fraud Licensing 52

Healthcare IT Today

DECEMBER 29, 2023

Sara Shanti, a partner specializing in health care technology at law firm Sheppard Mullin , says that the Executive Order and recent FDA guidance “start to provide real direction on how to navigate patient risk. Liability and Licensing Are clinicians facing the risk of lawsuits if they heed the advice of AI engines?

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Department of Veterans Affairs FDA Doctors Licensing 108

SQA

MAY 24, 2023

ANVISA has intercepted international shipments of Batch Number C6835C3 which presented a false description of content and contained bottles in packaging in the Turkish language with expirations dates 10/2024 (bottle) and 12/2024 (secondary packaging). The written procedure for recall was inadequate and this procedure had not been implemented.

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SQA

DECEMBER 16, 2022

The EC presented a first draft for public comment to the revision of Annex 1 in 2017. Since health authorities have not yet published guidelines for a comprehensive control strategy specific to microbiological topics for ATMPs, it is up to the individual ATMP sponsor or license holder to apply these compendial references properly.

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FDA Compliance COVID-19 Licensing 40

Healthcare Law Today

DECEMBER 19, 2022

market presents a tremendous opportunity for Israel-based health care companies, though the complexities and challenges of U.S. FDA Regulatory Considerations for the U.S. ” The U.S. health care delivery systems. law must be thoroughly understood. We will have a networking reception immediately following the program.

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Telemedicine FDA Licensing Governance 64

SQA

SEPTEMBER 2, 2022

The information presented in this guide is the combination of proven technological solutions, microbial control methods, process analytical technology, and operations and maintenance practices. United States Food and Drug Administration (FDA) – Regulations and Guidances. ISPE Good Practice Guide: Critical Utilities GMP Compliance.

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FDA COVID-19 Nursing Homes Compliance 91

SQA

OCTOBER 18, 2023

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections. about how they use sunscreen products.

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FDA Compliance Licensing World Health 40

SQA

DECEMBER 10, 2021

Pilot Program: EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products – General Principles, 15 September 2021. The agencies conduct PSA meetings under the auspices of the confidentiality arrangement between the European Commission, the EMA, and the FDA. European Medicines Agency (EMA). The EMA and the U.S.

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FDA Compliance Public Health Hospitals 52

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

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Healthcare Law Blog

MARCH 8, 2023

First, the Biologics License Application approval letter from the U.S. Food and Drug Administration (“FDA”) approved only a single manufacturing facility, which is located on the campus of the “Treatment Center.” Thus, the Drug can be administered only at the Treatment Center by a qualified surgeon.

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FDA Doctors Medicaid Medicaid 52

Healthcare IT News - Telehealth

MAY 6, 2020

Current Health is leveraging this data to better understand how the coronavirus presents and evolves across diverse populations via a partnership with the Mayo Clinic. It also equips providers with Eko’s FDA-cleared AI to assist in remote screening for AFib, heart murmurs, tachycardia and bradycardia. iRhythm Technologies.

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COVID-19 FDA Hospitals Elder Care 188

Healthcare Law Blog

JANUARY 12, 2022

A good portion of Cordani’s presentation was focused on Cigna’s Evernorth initiative, which includes pharmacy and benefits management (Express Scripts, eviCore), care (MDLive and behavioral health) and intelligence (analytics, predictive models) offerings. So, what can be done about that? Aledade also used the J.P.

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US Department of Health and Human Services Doctors Nurses Medicare 52

Hall Render

DECEMBER 1, 2023

to Recruit, Train Primary Care Students UAMS Gets $17.5M to hospitals Propella Therapeutics, Pittsboro firm with 5 employees, sold for $175M Winston-Salem’s clinical research organization Javara raises $9.43

Nursing Homes 40

Nursing Homes Nurses Ransomware COVID-19 40

SQA

OCTOBER 18, 2022

The counterfeit devices were sold online by a distributor named Healthful Plus without the required license to import, distribute, or sell medical devices in Canada. The packaging of the counterfeit kits resembles authentic (licensed) BTNX Inc. The ICH M12 Draft Guideline Presentation Available Now on the ICH Website, 15 July 2022.

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US Department of Health and Human Services FDA COVID-19 Compliance 40

Hall Render

MARCH 3, 2023

million for youth mental health care KENTUCKY Pike County nursing home officials release statement following loss of Medicare agreement Three Humana executives drop $11.2M

Nursing Homes 40

Nursing Homes COVID-19 Nurses Hospitals 40

Hall Render

FEBRUARY 18, 2022

License wait times reach crisis levels for healthcare workers. Meet new FDA chief Dr. Robert Califf: 5 things to know. Lack of ICU doctors presents challenges for healthcare in Idaho. A real crisis’: License backlogs in some states prevent health-care workers from seeing patients.

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COVID-19 Nursing Homes Nurses COVID-19 Vaccine 40

Hall Render

JUNE 9, 2023

High-level nursing officer from Houston hospital joins Baptist Memorial Hospital for Women Siloam Health names Katie Richards permanent CEO Upperline Health closes $58.35

Nurses 40

Nurses COVID-19 Nursing Homes Hospitals 40

AIHC

AUGUST 2, 2022

Suspect Case A suspected case is when a patient presents with a new characteristic rash or meets one of the epidemiologic criteria and has a high clinical suspicion for monkeypox. Two vaccines may be used for the prevention of Monkeypox virus infection: JYNNEOS (also known as Imvamune or Imvanex), licensed (or approved) by the U.S.

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US Department of Health and Human Services FDA Licensing Compliance 98

Hall Render

FEBRUARY 2, 2024

Inman College of Nursing FDA clears Collierville startup CircumFix’s medical device for surgery, marketing FTC opposes Novant Health’s $320M hospital deal with Community Health Systems HCA CFO to retire HCA nets $5.2B for Dental Health OakLeaf Medical Network reaches out to HSHS WYOMING Gov.

Nursing Homes 40

Nursing Homes US Department of Health and Human Services Nurses Hospitals 40

Hall Render

OCTOBER 6, 2023

federal contract to help school mental health workers WYOMING Wyoming Hospital Association presents inaugural Healthcare Leadership Awards Sheridan hospital board celebrates success of Wyoming Regional Emergency Medical Service St. medical school to revamp philanthropic efforts Sage Health opening 3 central Md.

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses Hospitals 40

Hall Render

OCTOBER 6, 2023

federal contract to help school mental health workers WYOMING Wyoming Hospital Association presents inaugural Healthcare Leadership Awards Sheridan hospital board celebrates success of Wyoming Regional Emergency Medical Service St. medical school to revamp philanthropic efforts Sage Health opening 3 central Md.

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses Hospitals 40

Hall Render

MARCH 25, 2022

FDA to revive facility visits. Moderna wants the FDA to authorize its COVID-19 vaccine for kids under 6. lawmaker presents plan to improve women’s healthcare. Nurses are frustrated by months-long delays to get licensed in some states. 5 healthcare companies get ‘F’ in racial and gender pay equity.

COVID-19 40

COVID-19 US Department of Health and Human Services Nursing Homes Nurses 40

SQA

FEBRUARY 26, 2024

During the operation, food supplements, cannabidiol in various presentations, testosterone, perfumes, and sibutramine tablets were identified, including about 6,000 units of electronic cigarettes and 35,500 packs of cigarettes. The products found, subject to retention and seizure, were retained by the Federal Revenue Service.

FDA 52

FDA Compliance COVID-19 Public Health 52

Kaiser Health News

APRIL 6, 2022

In presentations, they often share a 2017 study — conducted by an independent research institute at TROSA’s request — which found TROSA saves the state nearly $7.5 Other graduates interviewed for this article talked about using the moving skills or commercial driving licenses they gained to obtain full-time jobs.

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Licensing Public Health FDA Doctors 83

Hall Render

MARCH 24, 2023

operating loss Checking in on ProMedica’s $20M investment in a southeast Michigan city Cincinnati Children’s acquires long-time Kenwood practice led by Dr.

Nursing Homes 40

Nursing Homes Nurses COVID-19 Hospitals 40

Hall Render

JULY 29, 2022

COVID-19 cases rising in Oklahoma, new variant present. Portland device maker garners FDA breakthrough designation. Former Sanford doctor reprimanded for failing to disclose medical license renewal failure. Memphis nursing home still open after license suspended due to health & safety violations. PENNSYLVANIA.

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COVID-19 Nursing Homes Nurses Hospitals 40

Hall Render

JANUARY 12, 2024

Lima FLORIDA Allstate accuses Florida clinic of billing fraud, unnecessary spine surgeries Baptist Health, Compass Surgical Partners to launch ASC network Broward Health taps former Cleveland Clinic Florida CEO Cape Coral medical office building sells for $2.2M to settle improper billing allegations COVID-19 variant JN.1 1 ‘more transmissible’?

Nursing Homes 40

Nursing Homes US Department of Health and Human Services COVID-19 Nurses 40

Hall Render

NOVEMBER 3, 2023

Joe’s among busiest hospital ERs in nation, poll reveals New ASC, medical building proposed in New Jersey New Jersey hospital innovation director appointed to FDA committee New Jersey hospital rebuffs criticism from US senator Nurses testify that N.J.

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses Hospitals 40

Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. at *2 (citation omitted).

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FDA Medical Personnel Telemedicine Licensing 111

Drug & Device Law

NOVEMBER 1, 2022

Starting with the to-be-published Mixson I , this IVC filter case presented rather complex choice of law issues because the plaintiff implantee was in the military when the surgery in question occurred, and the army sent him to Texas for treatment, even though he was a Florida resident. 2022 WL 4364153, at *2. quoting Ariz. 12-689(A)(1)).

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FDA Fraud Licensing Governance 59

Drug & Device Law

AUGUST 8, 2022

For qualified IMGs, it issues a certification, which IMGs can then use to apply to residency and other graduate medical education programs and to apply for state medical licenses. Such power rests solely with the FDA.” The unfortunate truth is that ECFMG was also a victim of this fake doctor’s fraud. 2d 1036, 1050 (N.J.

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Doctors Fraud Licensing Compliance 52

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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FDA US Department of Health and Human Services COVID-19 Informed Consent 105