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News

JPM2023 Trendspotting: takeaways from Biotech Showcase

Hogan Lovells partners Alice Valder Curran, Jodi Scott, and Andrew Strong convened with other industry leaders at this year’s Biotech Showcase Investor conference to discuss how...

News

JPM2023 Trendspotting: takeaways from Biotech Showcase

Hogan Lovells partners Alice Valder Curran, Jodi Scott, and Andrew Strong convened with other industry leaders at this year’s Biotech Showcase Investor conference to discuss how...

News

FDA expands inspection obstruction guidance to apply to device facilities

The U.S. Food and Drug Administration (FDA) has published the revised draft guidance “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device...

News

JPM2023 Trendspotting: commercializing digital therapeutics

Caution remains a strong theme in the current market. But caution should not lead to paralysis. Now more than ever, companies must think strategically and be more nimble about attracting...

Hogan Lovells Podcasts

Podcast: Talking the cure

Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients. Over the next year, we will touch on cutting-edge topics such as...

News

FDA to regulate more AI & software tools as devices, guidance indicates

In the waning days of FDA’s fiscal year, the U.S. Food and Drug Administration (FDA) issued the greatly anticipated final guidance “Clinical Decision Support Software,”...

News

FDA plans to expand remote evaluations, record reviews post-pandemic

The U.S. Food and Drug Administration (FDA) recently issued draft guidance on how it will continue to conduct remote regulatory assessments (RRAs) after the COVID-19 public health emergency ...

News

FDA updates “cybersecurity in medical devices” guidance, seeks industry input

The U.S. Food and Drug Administration (FDA) issued updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket...

Insights and Analysis

FDA proposes to conform the Quality System Regulation to the ISO 13485 standard

On February 22, the U.S. Food and Drug Administration (FDA) published its long awaited proposed rule entitled, “Medical Devices; Quality System Regulation Amendments,” which...

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