The Pharma Data

DECEMBER 17, 2020

These follow-on data provided the first definitive prospective evidence demonstrating anti-viral activity for a treatment regimen now available for COVID-19, and also further documented the ability of this treatment to decrease the need for further medical attention,” said George D. Have chronic kidney disease. Have diabetes.

Hospitals 52

Hospitals Production Clinical Trials Virus 52

The Pharma Data

JANUARY 12, 2021

Definition of High-Risk Patients. Nursing Mothers: There is currently no clinical experience in use of casirivimab and imdevimab injection in COVID-19 patients who are breastfeeding. High-risk is defined as patients who meet at least one of the following criteria: Have a body mass index (BMI) ?35. Have chronic kidney disease.

Government 52

Government Hospitals Virus Production 52

The Pharma Data

DECEMBER 29, 2020

Definition of High-Risk Patients High-risk is defined as patients who meet at least one of the following criteria: — Have a body mass index (BMI) ?35 Nursing Mothers: There is currently no clinical experience in use of casirivimab and imdevimab injection in COVID-19 patients who are breastfeeding.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

NOVEMBER 20, 2020

Definition of High-Risk Patients. Nursing Mothers: There is currently no clinical experience in use of casirivimab and imdevimab injection in COVID-19 patients who are breastfeeding. High-risk is defined as patients who meet at least one of the following criteria: Have a body mass index (BMI) ?35. Are ?

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

The Pharma Data

NOVEMBER 21, 2020

Definition of High-Risk Patients. Nursing Mothers: There is currently no clinical experience in use of casirivimab and imdevimab injection in COVID-19 patients who are breastfeeding. High-risk is defined as patients who meet at least one of the following criteria: Have a body mass index (BMI) ?35. Have chronic kidney disease.

FDA 40

FDA Clinical Trials Hospitals Government 40

FDA Law Blog: Biosimilars

JUNE 23, 2024

1] Under the relevant definitions in the CSA, the dispensing/delivery of controlled substances is limited to the “ultimate user” ( i.e., the patient or a member of the patient’s household). [2] 1] 21 U.S.C. § 802 (27) (The CSA’s “ultimate user” definition). [2] 2] Why is this an issue? the “ultimate user”). 2] See, e.g. , id. §

Nurses 98

Nurses Pharmacy Regulations Therapies 98

Drug & Device Law

MAY 15, 2023

The relevant facts were quite concisely stated: In the fall of 2021, [plaintiff’s] 15-year-old [daughter] visited [defendant’s] pharmacy seeking to be vaccinated for COVID-19 without parental consent. includ[es] retail pharmacies. A court acting without “a rational and explainable basis” by definition abuses its discretion.

Vaccine 59

Vaccine Pharmacy Hospitals Licensing 59