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Publications

Hogan Lovells Podcasts

Podcast: Talking the cure

Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients. Over the next year, we will touch on cutting-edge topics such as...

News

Eleventh Circuit decision could significantly expand scope of orphan exclusivity

With the issuance of its mandate on January 28, 2022, in Catalyst Pharmaceuticals, Inc. v. Becerra, the U.S. Court of Appeals for the Eleventh Circuit has upheld the orphan exclusivity ...

News

FDA finalizes guidance on Orphan Drug “sameness” of gene therapies

Recently, the U.S. Food and Drug Administration’s (FDA’s) Office of Orphan Product Development published the four-page final guidance “Interpreting Sameness of Gene...

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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