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Drug Pricing Administrative Procedure

Goodwin

Charting a Conditional Approval Pathway for Rare Disease Drugs - A Top Priority for a Revamped FDA?

Goodwin on

On April 18, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary announced plans to roll-out a new approval pathway for rare disease drugs. ...more

Holland & Knight LLP

HHS Issues Proposed Rule to Overhaul 340B Administrative Dispute Resolution Process

Holland & Knight LLP on

Through its Health Resources and Services Administration (HRSA), the U.S. Department of Health and Human Services (HHS) issued a proposed rulemaking on Nov. 29, 2022, that would drastically overhaul the 340B Drug Pricing...more

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