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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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News

Final FDA combination product guidance encourages application-based feedback pathways

The U.S. Food and Drug Administration (FDA) recently finalized its guidance entitled “Requesting Food and Drug Administration Feedback on Combination Products,” stressing as it...

News

Labeling carve-out does not shield generic drug makers from induced infringement claims, CAFC rules

The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a labeling carve-out by a generic drug...

Insights

FDA Guidance on Combination Product Agreement Meetings lacks specificity, comments say
Registered Content

The public comment period recently closed for the draft guidance “Requesting FDA Feedback on Combination Products,” which describes the methods by which combination product...

Insights

“Misleading” to suggest a biosimilar is inferior, FDA draft guidance warns
Registered Content

As part of its continuing efforts to advance biologics competition, the U.S. Food and Drug Administration (FDA) on February 3 published a 10-page Q&A draft guidance, “Promotional...

Insights

FDA issues draft guidance regarding “sameness” for Orphan Drug gene therapies
Registered Content

On Tuesday, FDA’s Center for Biologics Evaluation and Research (CBER) finalized six gene therapy guidances drafted in July 2018. With the Office of Orphan Products Development (OOPD), ...

Insights

Spending bill advances FDA biosimilars policy
Registered Content

On December 20, U.S. President Trump signed into law H.R. 1865, the “Further Consolidated Appropriations Act, 2020” (the Act), authorizing appropriations through September 30,...

Insights

Combination product sponsors get a new meeting option under draft FDA guidance
Registered Content

The U.S. Food and Drug Administration (FDA) released a draft guidance, “Requesting Food and Drug Administration Feedback on Combination Products,” which outlines universal best...

Hogan Lovells Publications

A new normal in the pharmaceutical industry: How to fight back when your competitor can't stop fibbing Pharmaceutical and Biotechnology Alert

Center for Drug Evaluation and Research (CDER) Director Janet Woodcock, M.D., recently indicated that the Food and Drug Administration (FDA) is unlikely to take enforcement action against a ...

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