Publications

Hogan Lovells Publications

Expanding access to unapproved treatments through right-to-try

State-level right-to-try laws have given patients and their families hope that they might gain access to breakthrough investigational treatments. But traditionally, the FDA and...

Publications

FDA seizes stem cell cherapy — A first of many?

On August 25, 2017, U.S. Marshals Service, at the request of FDA, seized five vials of ACAM20000—a smallpox vaccine containing live vaccinia virus (cow pox), which is reserved for...

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...

Publications

Just One More Day Compliance Deadline for New ClinicalTrials gov Regulations is Tuesday April 18 2017

On 21 September 2016, the Department of Health and Human Services (HHS) published a final rule that clarified and expanded the requirements for clinical trial registration and results...

Hogan Lovells Publications

Ready, Set... Cures Act Expanded Across Policy Deadline Is Almost a Go

As we have mentioned in a previous article, the 21st Century Cures Act (enacted December 13, 2016) gave companies 60 calendar days to make their expanded access policies for certain...

Hogan Lovells Publications

HHS Overhauls the Common Rule to Enhance Protection for Human Subjects in Research

On 18 January 2017, as one of the last actions of the outgoing Obama Administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the Agencies) ...

Hogan Lovells Publications

A "Cure" for Combination Products: 21st Century Cures Act Mandates Greater Transparency of Combination Product Designations

The 21st Century Cures Act ushers in significant changes to the regulatory review of drug/biologic/device combination products. The regulation of combination products has been somewhat...

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