Publications

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 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...

Hogan Lovells Publications

Much to metabolize: The 21st Century Cures Act introduces numerous changes to FDA’s drug regulatory framework to spur development of new treatments

The 21st Century Cures Act (Cures Act) has become law with measures designed to deliver new cures and treatments to patients.  Among these measures are a broad range of changes to the...

Hogan Lovells Publications

It’s Final: Expanded Registration and Results Submission Requirements for ClinicalTrials.gov

On September 16, 2016, the Department of Health and Human Services (HHS) issued a final rule that “clarifies and expands” the requirements for clinical trial registration and...

Hogan Lovells Publications

FDA Takes Steps to Clarify Significant Human Tissue Questions

On October 30, 2015, the Food and Drug Administration (FDA) issued a draft guidance document, Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products (the Homologous...

Hogan Lovells Publications

Centers for Medicare & Medicaid Services (CMS) Requests Comments on National Coverage of Stem Cell Transplantation

On April 30, 2015, CMS opened a 30-day comment period for a National Coverage Analysis (NCA) on Stem Cell Transplantation. Currently, CMS has a National Coverage Determination (NCD) for...

Hogan Lovells Publications

FDA Publishes Draft Guidances and Memorandum of Understanding on Drug Compounding and Repackaging

On February 13, 2015, the FDA issued four draft guidance documents and a draft memorandum of understanding (MOU) regarding the compounding of drug and biological products and the regulation ...

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