On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support hub for innovative approaches to clinical trials designed to improve the quality and efficiency of drug development and regulatory decision-making. Following a public solicitation of comments on the barriers of clinical trial designs, FDA determined that the establishment of C3TI would enhance CDER’s ability to address those barriers and foster innovation.
The combination of the Coronavirus (COVID-19) pandemic and the imminent end of the Brexit transition period means a fast-changing regulatory environment for medicines.
In October 2020, the UK Government made changes to the regulation of medicines for COVID-19 and influenza. The regulations set out changes for the temporary authorisation of medicines (including COVID-19 vaccines) and allow the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to set conditions for that authorisation.
The challenges of the past year have underscored the importance of life sciences to a dramatic degree. With countries worldwide now distributing vaccines that were developed in record time, COVID-19 has also made plain the value of investing in technological and scientific solutions that can reshape the world and improve health outcomes.
The pandemic has particularly accelerated investments in the digital health space, as a significant share of everyday life has migrated to computer screens by necessity. So what does this mean for the sector going forward?
Writing for MPO Magazine, McDermott partner Steve Bernstein shares five themes to watch in the digital health sector, including what life sciences developers and investors should know about the current deal-making landscape.
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