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Publications

Hogan Lovells Publications

FDA and OHRP finalize joint guidance on IRB meeting minutes Focus on Regulation

The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), both part of the Department of Health and Human Services (HHS), issued final joint guidance ...

Publications

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

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

The New Hatch-Waxman Regulations: A First Look Pharmaceutical and Biotechnology Alert

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

International Product Liability Review - Issue 61 Product Liability Alert

The International Product Liability Review provides quarterly updates and comment from around the world on legal developments in the field of product liability and product safety.

Hogan Lovells Publications

Bring Your Own Smartphone: FDA Requests Comments on the Use of Innovative Technologies to Conduct Clinical Trials Pharmaceutical and Biotechnology and Medical Device Alert

On October 29, 2015, FDA issued a notice requesting comments on the use of new technologies – such as smart phones, tablets, and wearable technology – to recruit for and conduct drug...

Hogan Lovells Publications

Important New Steps in the Evolution of the Federal Policy for Protection of Human Subjects Pharmaceutical and Biotechnology and Medical Device Alert

On September 2, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a long-anticipated Notice of Proposed Rulemaking (NPRM) to overhaul...

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