FDA Law Blog: Biosimilars

OCTOBER 17, 2023

Background The Breakthrough Devices Program, established under section 515B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), is a voluntary program for certain medical devices and device-led combination products. By Philip Won & Lisa M. Wysa, see here ) and addiction (e.g., reSET-O, see here , here ).

Documentation 53

Documentation Medication Dispensing Hospitals 53

Proxsys Rx

APRIL 4, 2024

Medications dispensed through these clinics have high utilization rates, and yield equally high 340B savings. We handle the rest of the process — painstakingly documenting everything we do, and reporting back to the health systems at every critical step. Fortunately, those steps tend to be the least burdensome in the process.

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Insurance Coverage and Processing Medication Dispensing 52

Proxsys Rx

AUGUST 22, 2023

Medications dispensed through these clinics have high utilization rates, and yield equally high 340B savings. We handle the rest of the process — painstakingly documenting everything we do, and reporting back to the health systems at every critical step. Fortunately, those steps tend to be the least burdensome in the process.

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Insurance Coverage and Processing Medication Dispensing 52

Proxsys Rx

DECEMBER 22, 2023

Medications dispensed through these clinics have high utilization rates, and yield equally high 340B savings. We handle the rest of the process — painstakingly documenting everything we do, and reporting back to the health systems at every critical step. Fortunately, those steps tend to be the least burdensome in the process.

Specialty Pharmacies 40

Specialty Pharmacies Hospitals Insurance Coverage and Processing Medication Dispensing 40