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Food and Drug Administration (FDA) Drug Pricing Medical Research

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

Holland & Knight LLP

Holland & Knight Health Dose: April 29, 2025

Holland & Knight LLP on

U.S. Congress returns from a two-week recess this week and has lofty goals to draft, mark up and pass a reconciliation bill by Memorial Day 2025. The U.S. House of Representatives Committee on Energy and Commerce, which was...more

Foley & Lardner LLP

New Mexico Becomes Third State in the U.S. to Legalize Access to Psilocybin

Foley & Lardner LLP on

On April 7, 2025, New Mexico Governor Michelle Lujan Grisham signed into law SB-219, the Medical Psilocybin Act (the Act), making New Mexico the third state in the country to create a legal pathway for patients to access...more

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