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.

Drugs 59

Drugs FDA Hospitals Government 59

Drug Channels

SEPTEMBER 22, 2023

In this article, Kristina reviews how brands can help patients make connections that address medication affordability challenges, whether at the prescriber’s office, the pharmacy, or at home. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc. Read on for Kristina’s insights.

Pharmacy 98

Pharmacy Production Drugs 98

Drug Channels

SEPTEMBER 22, 2023

In this article, Kristina reviews how brands can help patients make connections that address medication affordability challenges, whether at the prescriber’s office, the pharmacy, or at home. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc. Read on for Kristina’s insights.

Pharmacy 97

Pharmacy Production Drugs 97

Conversations in Drug Development Trends

FEBRUARY 21, 2024

Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure. Here are a few of our lessons learned: 1.

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Clinical Trials Pharmacy Clinical Pharmacology FDA 80

Drug Channels

FEBRUARY 23, 2021

Let’s melt away this foul February with our monthly selection of scorching news from around the drug channel. 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!

Pharmacy 52

Pharmacy Specialty Pharmacies Hospitals Independent Pharmacies 52

The Pharma Data

NOVEMBER 20, 2020

According to a benchmarking survey by TraceLink , 532 global supply chain leaders from various leading pharma companies, wholesale distributors, hospitals and pharmacies have indicated the supply chain has been severely impacted by the Covid-19 pandemic.

Pharma Companies 52

Pharma Companies Vaccine Pharmacy Drugs 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.

Regulations 40

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