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Public Health Manufacturers Drug Pricing

Sheppard Mullin Richter & Hampton LLP

HRSA Launches and Seeks Comments on 340B Rebate Model Pilot Program

On August 1, 2025, the Health Resources and Services Administration (“HRSA”) issued a Notice announcing the launch of the 340B Rebate Model Pilot Program (“Pilot Program”), that would dramatically change the way in which...more

Gardner Law

The Value of MDUFA

Gardner Law on

Anyone who has submitted a medical device for pre-market review knows the financial investment it takes to for FDA to conduct its review. Under the Medical Device User Fee Amendments (MDUFA), certain submissions, including...more

Foley & Lardner LLP

Are Drug Prices Really Too High?

Foley & Lardner LLP on

Those working in the pharmaceutical space are used to hearing complaints about the high costs of drugs, and patents often are blamed for allowing pharmaceutical companies to charge “too much” for their products. But are drug...more

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