FDA Law Blog: Biosimilars

JULY 31, 2023

Three years after that letter, DEA proposed a rule to amend its regulations consistent with CARA on December 20, 2020. Now, in July 2023, DEA has finally issued its final rule amending its regulations for partial filling of prescriptions for schedule II substances. 78,282 (Dec. 46,983 (July 21, 2023). The Final Rule a.

Long-Term Care Facilities 98

Long-Term Care Facilities Pharmacy Regulations Drugs 98

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.

Vaccine 52

Vaccine Trials Long-Term Care Facilities FDA 52

The Pharma Data

DECEMBER 4, 2020

Having beat the United States to emergency authorization may pressure American regulators, who are already taking heat for not moving faster to get doses to people, the Times reported. An FDA advisory panel is set to meet on Dec. 10 to decide whether the agency should grant emergency authorization to the Pfizer vaccine, the Times reported.

Vaccine 52

Vaccine Long-Term Care Facilities Nurses Hospitals 52

The Pharma Data

DECEMBER 3, 2020

Having beat the United States to emergency authorization may pressure American regulators, who are already taking heat for not moving faster to get doses to people, the Times reported. An FDA advisory panel is set to meet on Dec. 10 to decide whether the agency should grant emergency authorization to the Pfizer vaccine, the Times reported.

Hospitals 52

Hospitals Vaccine Long-Term Care Facilities Nurses 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 40

Long-Term Care Facilities Virus FDA Regulations 40

The Pharma Data

OCTOBER 28, 2020

Discussions with global regulators are ongoing. 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.

Government 40

Government Long-Term Care Facilities Hospitals Therapies 40

The Pharma Data

MARCH 5, 2021

of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. 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.

Treatment 40

Treatment Hospitals Long-Term Care Facilities Therapies 40