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Pharmaceutical Industry › Orphan Drugs › New Guidance

Akin Gump Strauss Hauer & Feld LLP

FDA Continues Focus on Rare Disease Drug Development, Announces Evidence Principles

Akin Gump Strauss Hauer & Feld LLP on

On September 3, 2025, the Food and Drug Administration (FDA) announced Rare Disease Evidence Principles (RDEP) with processes aimed at providing greater predictability and facilitating the development and review of drugs...more

Cornerstone Research

Potential Unintended Economic Impacts of the Inflation Reduction Act on the Pharmaceutical Industry

Cornerstone Research on

The Inflation Reduction Act (IRA) was signed into law in August 2022 with the goal of curbing inflation by, among other things, lowering prescription drug prices. Notable prescription drug provisions of the IRA include the...more

Hogan Lovells

FDA finalizes guidance on Orphan Drug “sameness” of gene therapies

Hogan Lovells on

Recently, the U.S. Food and Drug Administration’s (FDA’s) Office of Orphan Product Development published the four-page final guidance “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations,” which...more

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