Publications

Hogan Lovells Publications

FDA guidances promote greater communication to payors about medical product value

On June 12, FDA finalized two guidance documents regarding the types of information that drug and device manufacturers may communicate to payors and that the agency regards as...

Hogan Lovells Publications

Life sciences and health care horizons

Hogan Lovells Publications

Digital Health: The issues you need to consider to leverage its full potential in 2018

Technology is changing the way the healthcare industry operates, bringing huge potential for untapped business opportunity. At the same time, with these changes comes a dramatic shift in...

Hogan Lovells Publications

In The Midnight Hour: FDA Issues 2 Draft Guidances and a First Amendment Memorandum on the Cusp of a New Administration

Over the past few days, FDA issued three documents related to the scope of permissible communications by drug and device companies to various parties. We believe FDA aimed to accomplish two ...

Hogan Lovells Publications

FDA Clarifies "Intended Use" Regulations: Knowledge Alone ≠ Intent, But Knowledge Certainly Can Be One Element in Establishing the Totality of the Evidence

In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug Administration (FDA) amended the intended...

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

FDA got an earful: FDA’s Part 15 public hearing on manufacturer communications regarding unapproved uses of approved or cleared medical products

Last week, FDA held a much-anticipated Part 15 public hearing seeking commentary on its regulation of speech about unapproved uses of approved products. As the agency noted in its Federal...

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...

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