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Biotechnology › Medical Devices › Regulatory Reform

Knobbe Martens

Bipartisan Law Introduced to Clarify Patent Eligibility

Knobbe Martens on

For the past decade, controversy regarding the laws of patent eligibility has created uncertainty in the minds of inventors and investors, especially in the biotechnology, medical diagnostics, and software industries adjacent...more

Alston & Bird

Feds Continue to Reform Approach to Regulation of Biotech Products

Alston & Bird on

Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more

Hogan Lovells

FDA proposes clarification in long-running tussle over “intended use” rules for drugs and devices

Hogan Lovells on

On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations to clarify the types of evidence FDA will consider when determining the “intended use” of a medical...more

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