FDA Law Blog: Biosimilars

JULY 31, 2023

In addition, a pharmacist could partially fill a schedule II prescription issued to patients in a Long Term Care Facility or who have a terminal medical illness diagnosis. The Final Rule a.

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Long-Term Care Facilities Pharmacy Regulations Drugs 98

The Pharma Data

NOVEMBER 8, 2020

Ready-to-dilute and room temperature stable, Sesquient is the only FDA-approved fosphenytoin that allows point-of-care storage, as well as fast and efficient administration in emergency rooms, intensive care units, first responder vehicles, and long-term care facilities, where serial seizures such as status epilepticus are most commonly treated.

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FDA Approval FDA Long-Term Care Facilities Treatment 52

The Pharma Data

SEPTEMBER 18, 2020

Olivia Karpinski, vice-president of sales at Vivera Pharmaceuticals, said: “We have worked closely with our customers, including long-term care facilities and hospital networks, to provide efficient solutions for their increased testing needs.”

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Vaccine Long-Term Care Facilities Clinical Supply Laboratories 52

The Pharma Data

FEBRUARY 1, 2021

million shots have now been administered in long-term care facilities, according to the U.S. . “That combination really does make me think this is not just broad national patterns, but that vaccines probably are playing a role,” Dr. Jha said. “I’m optimistic, this is good.”

Nurses 52

Nurses Vaccine Long-Term Care Facilities Virus 52

PPD

MAY 11, 2023

These settings range from senior villages, where the elderly live independently, to long-term care facilities, where the elderly rely on assistance for daily living. Aging patients may live on their own in a community dwelling or in a setting where assistance is provided.

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Vaccine Clinical Trials Long-Term Care Facilities Trials 52

The Pharma Data

DECEMBER 17, 2020

Currently, healthcare personnel and long-term care facility residents participating in their trial are the only ones who can opt to receive the vaccine.

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Vaccine Trials Long-Term Care Facilities FDA 52

The Pharma Data

JANUARY 24, 2021

National Institute of Allergy and Infectious Diseases (NIAID), of bamlanivimab (LY-CoV555) decreased the risk of COVID-19 among residents and staff of long-term care facilities, i.e., nursing homes. Eli Lilly announced that its BLAZE-2 clinical trial conducted with the U.S.

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Long-Term Care Facilities Trials Virus Clinical Trials 52

The Pharma Data

DECEMBER 10, 2020

First in line are health care personnel and residents and staff of long-term care facilities, according to earlier recommendations released by the CDC panel. Centers for Disease Control and Prevention will also vote on whether to recommend the vaccine and for whom, the Post reported.

Vaccine 52

Vaccine FDA Long-Term Care Facilities Hospitals 52

The Pharma Data

DECEMBER 4, 2020

The recommendation from the Advisory Committee on Immunization Practice (ACIP), if heeded, will steer the initial short supply of vaccines to about 21 million health care personnel and 3 million Americans working or living in long-term care facilities. An FDA advisory panel is set to meet on Dec.

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Long-Term Care Facilities Vaccine Nurses Hospitals 52

The Pharma Data

DECEMBER 3, 2020

The recommendation from the Advisory Committee on Immunization Practice (ACIP), if heeded, will steer the initial short supply of vaccines to about 21 million health care personnel and 3 million Americans working or living in long-term care facilities. An FDA advisory panel is set to meet on Dec.

Hospitals 52

Hospitals Long-Term Care Facilities Vaccine Nurses 52

The Pharma Data

JUNE 25, 2021

health care workers, long-term care facility workers, and workers in occupational or industrial settings in which close contact is common. Such individuals included, but were not limited to, those who shared a household, those living in institutional residences (military lodging, dormitories, etc.),

Trials 52

Trials Long-Term Care Facilities Virus Government 52

The Pharma Data

DECEMBER 31, 2020

According to the Times , he said that health care facilities are still learning how to store the vaccines at super-low temperatures, and many states are setting aside doses for use at long-term care facilities, an effort that’s expected to take several months.

Vaccine 52

Vaccine Long-Term Care Facilities Virus Hospitals 52

The Pharma Data

JANUARY 24, 2021

The test can help identify infected individuals in 15 minutes and is designed for at-home or point-of-need settings such as long-term care facilities, schools, or sporting events. It can be administered by healthcare professionals or untrained users.

Long-Term Care Facilities 52

Long-Term Care Facilities Virus FDA Regulations 52

Agency IQ

SEPTEMBER 6, 2023

OPP recommends that applicants utilize these methods to support the registration of disinfectant products with claims for efficacy against viruses and bacteria when used on soft-porous surfaces Surfaces in clinical and/or institutional environments (non-residential) are within the scope of this guidance and include non-clothing fabrics and textiles/upholstery (..)

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Production Virus Long-Term Care Facilities Laboratories 40

The Pharma Data

APRIL 14, 2021

A Phase 3 study of bamlanivimab alone or bamlanivimab and etesevimab together in residents and staff at long-term care facilities (BLAZE-2, NCT04497987 ) is also ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.

Government 52

Government Long-Term Care Facilities Hospitals Treatment 52

The Pharma Data

OCTOBER 28, 2020

A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing. A Phase 2 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing.

Government 40

Government Long-Term Care Facilities Hospitals Therapies 40

The Pharma Data

DECEMBER 2, 2020

The recommendation from the Advisory Committee on Immunization Practice (ACIP), if heeded, will steer the initial short supply of vaccines to about 21 million health care personnel and 3 million Americans working or living in long-term care facilities.

Vaccine 40

Vaccine Long-Term Care Facilities Hospitals Nurses 40

The Pharma Data

APRIL 16, 2021

A Phase 3 study of bamlanivimab alone or bamlanivimab and etesevimab together in residents and staff at long-term care facilities (BLAZE-2, NCT04497987 ) is also ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.

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Treatment Hospitals Long-Term Care Facilities Virus 52

The Pharma Data

DECEMBER 19, 2020

Today’s ACIP recommendation follows the December 1, 2020 ACIP recommendation for a Phase 1a rollout in which the first priority for COVID-19 vaccines is given to healthcare personnel treating patients and residents in long-term care facilities. Department of Health and Human Services (HHS) for review and adoption.

Vaccine 52

Vaccine Long-Term Care Facilities FDA Licensing 52

The Pharma Data

NOVEMBER 9, 2020

A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing. A Phase 2 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing.

Treatment 52

Treatment FDA Hospitals Long-Term Care Facilities 52

The Pharma Data

MARCH 5, 2021

A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987 ) is also ongoing. A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501 ) is ongoing.

Treatment 40

Treatment Hospitals Long-Term Care Facilities Therapies 40

The Pharma Data

JANUARY 26, 2021

A Phase 3 study of bamlanivimab alone or bamlanivimab and etesevimab together in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing. A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing.

Hospitals 52

Hospitals Treatment Long-Term Care Facilities Trials 52

The Pharma Data

MARCH 11, 2021

A Phase 3 study of bamlanivimab alone or bamlanivimab and etesevimab together in residents and staff at long-term care facilities (BLAZE-2, NCT04497987 ) is also ongoing. A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501 ) is ongoing.

Hospitals 40

Hospitals Trials Long-Term Care Facilities Treatment 40

The Pharma Data

MAY 4, 2021

A Phase 3 study of bamlanivimab alone or bamlanivimab and etesevimab together in residents and staff at long-term care facilities (BLAZE-2, NCT04497987 ) is also ongoing. Results from the Phase 2 cohorts of BLAZE-1 were published in the New England Journal of Medicine and The Journal of the American Medical Association.

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Therapies Hospitals FDA Approval Long-Term Care Facilities 52