Publications

Publications

There'll be some changes made: President signs prescription drug and biologic user fee reauthorization act

On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and...

Hogan Lovells Publications

FDA Announces Major Proposed Rule Amending Hatch-Waxman Regulations

On February 6, 2015, the Food and Drug Administration (FDA) published in the Federal Register (FR) a comprehensive proposed rule (80 FR 6802) to amend agency regulations governing...

Hogan Lovells Publications

FDA Revises Forms for Submission of Patent Information to the Orange Book: Federal Circuit Decision in Novartis AG v. Lee Alters Patent Term Adjustment

Two recent developments will affect the listing of patent information with pharmaceutical products approved by the U.S. Food and Drug Administration (FDA). First, the FDA has revised the...

Hogan Lovells Publications

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

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...

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