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 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

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

DECEMBER 2, 2020

Having beat the United States to emergency approval of a coronavirus vaccine may pressure American regulators, who are already taking heat for not moving faster to get doses to people, The New York Times reported.

Vaccine 40

Vaccine Long-Term Care Facilities Hospitals Nurses 40

The Pharma Data

NOVEMBER 9, 2020

Lilly is in discussions with global regulators to make bamlanivimab available around the world. 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 52

Treatment FDA Hospitals Long-Term Care Facilities 52

Agency IQ

SEPTEMBER 6, 2023

A pesticide is any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant, or any nitrogen stabilizer. All pesticides sold or distributed in the U.S.

Production 40

Production Virus Long-Term Care Facilities Laboratories 40