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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.
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02 April 2024
The Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and...
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21 February 2024
Speaking at the J.P. Morgan Healthcare Conference this year, Hogan Lovells life sciences regulatory partners Lowell Zeta and Blake Wilson, were joined by Greenleaf Health’s Kalah...
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21 February 2024
Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring...
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17 February 2024
The U.S. Food and Drug Administration (FDA) continues its efforts to include diverse participants in clinical research with a newly-published revision to its draft guidance document...
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09 January 2024
The U.S. Food and Drug Administration (FDA) has published a final rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical...
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09 January 2024
The U.S. Food and Drug Administration (FDA) has published a final rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical...
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05 January 2024
An already challenging financing market can seem especially daunting for innovative technologies that seek to go beyond merely treating a disease in order to promote healthy longevity....
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04 January 2024
Despite continued perceived economic headwinds, cutting edge research continues to provide new opportunities for life saving therapies for patients. However, early development programs for...
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14 December 2023
The U.S. Food and Drug Administration (FDA) signaled that it intends to finalize its laboratory developed test (LDT) proposed rule by April 2024. The new rule (if finalized as...
