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MedTech 2023: Key takeaways from conversations on women’s health, antitrust, and AI

AdvaMed recently hosted its annual MedTech Conference in Anaheim, California, at which Hogan Lovells lawyers and regulatory specialists convened with business leaders, scientists,...

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Life Science Law Update – Key developments for pharma & device companies in EU

In this Q3/23 issue of our Life Science and Health Care Law Update, our teams highlight key trends across life sciences regulatory, corporate, compliance, competition, and privacy...

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Informed consent duties for IRBs, investigators, and sponsors detailed in FDA final guidance

Nine years after the draft version was published, the Food and Drug Administration (FDA) has finalized its guidance on informed consent for sponsors, institutions, IRBs, and investigators....

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Regulatory considerations on artificial intelligence for health of the WHO

The World Health Organization ("WHO") published key principles for regulating artificial intelligence (AI) for health on 19 October 2023. The document, titled ‘Regulatory...

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FDA broadens scope on communication about unapproved uses to HCPs

The U.S. Food and Drug Administration (FDA) published new draft guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...

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Post-COVID, FDA still permits changes to non-invasive remote monitoring devices without 510(k)

The U.S. Food and Drug Administration (FDA) has revised its guidance on non-invasive remote monitoring devices used to support at-home patient monitoring, replacing its March 2020 guidance...

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Getting START’ed: New FDA programs aim to advance drugs to treat rare diseases

On September 29, 2023, the U.S. Food and Drug Administration (FDA or "agency") announced the opportunity for a limited number of sponsors to participate in a new pilot program...

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FCC proposes a new cybersecurity labeling program for Internet of Things devices*

The Federal Communications Commission (FCC) has proposed a new voluntary cybersecurity labeling program intended to provide consumers easily understandable information about the security of ...

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Getting START’ed: New FDA programs aim to advance drugs to treat rare diseases

On September 29, 2023, the U.S. Food and Drug Administration (FDA or "agency") announced the opportunity for a limited number of sponsors to participate in a new pilot program...

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