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

Guide to Recent Biosimilar Activity by FDA and in the Supreme Court

The U.S. Food and Drug Administration (FDA) recently completed a flurry of activity to help define the biosimilar pathway, including issuing final guidances on biosimilar clinical...

Hogan Lovells Publications

The New Hatch-Waxman Regulations: A First Look

On October 6, 2016, FDA published a final rule implementing portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) that govern ANDAs 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...

;
Loading data