Pharmacy Times

JUNE 23, 2025

This pathway’s expanded use and shifting Centers for Medicare & Medicaid Services (CMS) policies are reshaping reimbursement practices and therapeutic equivalence standards for 505(b)(2) drugs. It is basically an essential copy, and the pharmaceutical manufacturer has to show bioequivalence to the reference product,” Soefje said.

Pharmacy Technician

PharmaTech

AUGUST 1, 2025

The industry's dependence on geopolitical stability and predictable trade relationships is increasingly critical for global pharmaceutical manufacturing. Tariffs disrupt supply chains, impacting both finished products and raw materials, complicating compliance and cost forecasting. Share your voice!

Dosage

FDA Law Blog: Biosimilars

APRIL 16, 2024

Vanda Pharmaceuticals, Inc. Under the Medicaid Drug Rebate statute, a pharmaceutical manufacturer whose drug prices increase faster than the rate of inflation must pay additional per-unit rebates to the program. NDA or BLA drugs). Centers for Medicare and Medicaid Servs., 23-1457 (4th Cir.

Dosage

Viseven

JANUARY 13, 2023

Defining Drugs Dosage Even when all stages of the clinical trial are over, there are still many things pharmacists and doctors may learn after patients will get access to the new treatment. HEOR Analysis of Patients The social value of the drug in increasing the quality of life is also an important issue.

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