Publications

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...

Hogan Lovells Publications

May the Truth Set You Free: Amarin Prevails In Its First Amendment Case Against FDA

On August 7, 2015, the U.S. District Court for the Southern District of New York ruled in favor of Amarin Pharma, Inc. (Amarin) in its suit against the U.S. Food and Drug Administration...

Published Works

FDA Proposes Electronic Labels Rule for Drugs

Published Works

5 Pharma Ad Enforcement Trends To Watch

Prescription drug promotion is suddenly in a state of tremendous flux, with the legal landscape shifting rapidly amid court decisions on free speech, the Affordable Care Act’s emphasis on...

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