Publications

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

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FDA Issues Draft Guidance on Informed Consent Regulations

On July 15, 2014, the Food and Drug Administration announced a new Draft Guidance, Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors.

Published Works

FDA Still Working on 'Breakthroughs'

Published Works

FDA Still Working on 'Breakthroughs'

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