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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

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Publications

News

FDA quietly withdraws plans for a Devices Referencing Drugs regulatory approval pathway

The U.S. Food and Drug Administration recently withdrew its plans for a “Devices Referencing Drugs” (DRD) regulatory approval pathway, which it had proposed in September 2017....

News

HHS announces public meeting on ways to accelerate clinical innovation

Government seeks industry comment on expediting medical product development.

News

FDA guidance may ease path to biosimilar interchangeability Focus On Regulation

On 10 May 2019 the U.S. Food and Drug Administration (FDA) published the final guidance, "Considerations in Demonstrating Interchangeability With a Reference Product," which is intended to...

Hogan Lovells Publications

FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents, seek public comment Focus On Regulation

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will take to ensure that the Orange Book (FDA's publication of Approved Drug...

News

FDA mulls Orange Book overhaul to address patent listing, therapeutic equivalence, other issues

FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved Drug Products with Therapeutic...

Hogan Lovells Publications

D.C. Circuit Issues Landmark Ruling for Stem Cell Therapies Pharmaceutical and Biotechnology Alert

The D.C. Circuit has issued a ruling that will shape the future development of stem cell therapy in the United States. Through its February 4 decision, the court has broadly upheld FDA's...

Hogan Lovells Publications

FDA denies 5-year exclusivity to “stable esters” and confirms structure-based approach to exclusivity Pharmaceutical and Biotechnology Alert

For sponsors developing new chemical structures based on previously approved active ingredients, two new FDA decisions offer a clear – though hardly satisfying – standard for determining...

Published Works

Two Draft Guidances Seek to Clarify and Potentially Expand FDA Classification of Device and Drug Products - Hidden Risks and Unexpected Benefits The Food and Drug Law Institute Update

Two Draft Guidances Seek to Clarify and Potentially Expand FDA Classification of Device and Drug Products - Hidden Risks and Unexpected Benefits." The Food and Drug Law Institute Update,...

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