Publications

Hogan Lovells Publications

HHS announces public meeting on ways to accelerate clinical innovation

Government seeks industry comment on expediting medical product development

Hogan Lovells Publications

U.S. Supreme Court rules judges must decide whether preemption applies, and clarifies when it does

Opinion highlights importance of a "clear" record at FDA

Hogan Lovells Publications

New OMB review process could impede FDA issuance of guidance documents

Starting on 11 May 2019 there will be an additional layer of government review that may slow down the issuance of certain U.S. Food and Drug Administration (FDA) guidance documents.

Hogan Lovells Publications

FDA resumes enforcement relating to laboratory developed tests

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

An intelligent approach for regulating medical device AI

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

Influencer promo guide: Best practices for drug and device firms

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...

Hogan Lovells Publications

FDA addresses industry feedback on routine inspections by formalizing processes and standards in a draft guidance

On 29 March 2019 the U.S. Food and Drug Administration's (FDA) Office of Regulatory Affairs issued a draft guidance document titled "Review and Update of Device Establishment Inspection...

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