Audio
K&L Gates LLP | USA | 5 Mar 2024
In this Episode, Rebecca Schaefer, Michael Hinckle, and Elisabeth Lewis summarize FDA regulatory developments from 2023 and what to expect in…
McDermott Will & Emery | USA | 27 Feb 2024
On February 13, 2024, the US Food and Drug Administration (FDA) issued draft guidance entitled Use of Data Monitoring Committees in Clinical Trials…
Covington & Burling LLP | Germany | 12 Feb 2024
Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented…
Taylor Wessing | USA | 17 Jan 2024
Cautious optimism was the prevailing attitude amongst biotech CEOs and investors. Here we've broken down the key themes of discussion at this year's…
Taylor Wessing | European Union, Germany | 11 Jan 2024
In a strategy paper published by the German Federal Government on 13 December 2023, key goals were set to strengthen Germany as a research and…
Taylor Wessing | European Union, Germany | 10 Jan 2024
Unbürokratische Zulassungen für klinische Prüfungen mit Arzneimitteln, leichterer Zugang zu Gesundheitsdaten für Forschungszwecke, Anreize zur…
HGF Ltd | United Kingdom | 4 Jan 2024
In an unprecedented move, the MHRA has approved a CRISPR gene editing therapy ‘Casgevy’ for the treatment of sickle cell disease and…
Covington & Burling LLP | China, Hong Kong | 3 Jan 2024
In his 2023 Policy Address on October 25, 2023 (“Policy Address”), the Hong Kong Chief Executive officially proposed to establish a preparatory office…
Covington & Burling LLP | China | 21 Dec 2023
As the New Year approaches, companies conducting clinical trials in China may want to consider a new regulation that will become effective in March…
Sidley Austin LLP | USA | 15 Dec 2023
Earlier this month, the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) declined to establish new safe harbors…