Publications

Hogan Lovells Publications

Outlook for OTC drug regulation

Significant change is on the horizon for the over-the-counter (OTC) drug industry. OTC drug sales have grown from about US$3 billion in 1972 to over US$34 billion today, with over 300,000...

Hogan Lovells Publications

Life sciences and health care horizons

Hogan Lovells Publications

New legislation increases access to medical products for military applications

Today, the President signed new legislation that gives the Department of Defense (DoD) new opportunities to advocate to FDA for expedited development, review, and Emergency Use...

Publications

FDA seizes stem cell therapy — 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...

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