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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

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.

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The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation”

FDA Law Blog: Biosimilars

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 59
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What is HEOR in Pharma?

Viseven

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.