Hogan Lovells Publications

12 April 2019

Our team of compliance lawyers and regulatory science professionals has over 100 years combined experience working with medical device companies. To complement our extensive real-world,...

Hogan Lovells Publications

11 April 2019

On April 4, 2019, the U.S. Food and Drug Administration's (FDA or the agency) Office of In Vitro Diagnostics and Radiological Health issued a Warning Letter to Inova Genomics Laboratory in...

Hogan Lovells Publications

09 April 2019

In a welcome move, on 1 April 2019 the U.S. Food and Drug Administration (FDA) proposed reducing regulatory requirements for a number of radiation-emitting electronic products, including...

Hogan Lovells Publications

08 April 2019

Life sciences’ biggest innovations are often developed by young, first-time entrants to the marketplace. But promising product or not, many of these companies struggle in navigating a ...

Hogan Lovells Publications

05 April 2019

Hogan Lovells has been at the forefront of advising our clients on the clearance or approval of an increasing number of software as a medical device (SaMD) products and other medical...

Hogan Lovells Publications

05 April 2019

All companies must be mindful of compliance with Federal Trade Commission (FTC) guidelines for influencers and marketers, which require, among other things, that ads and endorsements be...