FDA Law Blog: Biosimilars

APRIL 8, 2024

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.

Drugs 59

Drugs FDA Hospitals Government 59

Drug Channels

FEBRUARY 23, 2021

In this issue: Payers confess: Patients lose from copay accumulators Humana joins the Express Scripts GPO Hospitals vs. PBMs over specialty pharmacy white bagging Let’s all follow the Buy-and-Bill Dollar! Plus, entrepreneurial pharmacy owner Dave Marley demonstrates the power of innovation. See page 15 (reproduced below).

Pharmacy 52

Pharmacy Specialty Pharmacies Hospitals Independent Pharmacies 52

Agency IQ

APRIL 12, 2024

ACRO’s white paper also highlights the potential for “enhanced efficiency, long-term cost savings, and faster collection of data” through risk-based monitoring and other data collection efficiencies. This also may include advice on the use of DHTs in clinical trials or post-market studies subject to the FDA’s regulation.”

Regulations 40

Regulations Trials Science Clinical Trials 40