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Hogan Lovells | USA | 29 Apr 2021

First company receives FDA violation notice for submission omission

On April 27, 2021, the U.S. Food and Drug Administration (FDA) issued its first Notice of Noncompliance to a company for failing to submit required…

Oh-Ebashi LPC & Partners | Japan | 27 Apr 2021

先発医薬品の承認申請に必要な臨床試験が特許法69条1項の 「試験又は研究のためにする特許発明の実施」に当たることを認めた事例

本件は、発明の名称を「ウイルスおよび治療法における それらの使用」とする発明(「本件発明」)の特許権者であ る原告X(大学教授)…

Kan-Tor & Acco | Israel, USA | 16 Apr 2021

Israel -United States Treaties, Agreements, and Collaborations facilitate new medical treatments

Albert Einstein, probably the world’s most renowned scientist was one of the founders of the Hebrew University in Jerusalem. His wisdom and foresight…

PLMJ | Portugal | 7 Apr 2021

Clinical trials in Portugal

Research and development ("R&D") of medicinal products is fundamentally important in peoples’ daily lives. This is true both from an individual…

PLMJ | Portugal | 7 Apr 2021

Clinical trials during COVID-19 pandemic

Clinical trials are a universally recognised method of performing research and development activities. The COVID-19 pandemic has made clinical trials…

Hogan Lovells | USA | 25 Mar 2021

Safeguarding drug development at academic institutions

Academic institutions and faculty engaged in developing novel drug therapies are navigating an increasingly complex compliance landscape. Innovative…

Hogan Lovells | China, European Union, Global, etc. | 23 Feb 2021

Life sciences and health care horizons 2021

At the beginning of 2020, no one would have Predicted the COVID-19 pandemic and the global Health crisis it would create. Nor would they…

Villaraza & Angangco | Philippines | 16 Feb 2021

TRIAL WITHOUT ERROR: Philippine FDA Issues Guidelines on COVID-19 Clinical Trial Applications

In an effort to Foster a clear, simplified, and transparent process for the conduct of clinical trials Of prospective COVID-19 treatments and vaccines…

Baker McKenzie | Italy | 12 Feb 2021

Italy: COVID-19 - AIFA publishes 19th National Report on Clinical Trials on Medicinal Products

On 30 December 2020, the AIFA published the 19th National Report on Clinical Trials on Medicinal Products providing data relating to 2019 ("Report")…

Hogan Lovells | USA | 12 Nov 2020

A step in the right direction: Encouraging diversity in clinical trial populations

On November 9, 2020, the U.S. Food and Drug Administration (FDA) released a final version of its guidance, Enhancing the Diversity of Clinical Trial…
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