Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
On 11 January 2021, the European Commission published a Notice which provides the conditions under which remote audits under Regulation 2017/745 of 5 April 2017 on medical devices (MDR) and Regulation 2017/746 of the of 5...more
In Tuesday's Report: a panel discussion on the U.S. election, Americans warned of COVID-19 surge, Moderna files for FDA EUA, Hong Kong proposes corporate rescue bill, new Foreign Direct Investment rules in Spain, the EU moves...more
12/1/2020
/ Biden Administration ,
Biotechnology ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Foreign Direct Investment ,
Hong Kong ,
Infections ,
Infectious Diseases ,
Insolvency ,
Joint Task Force ,
Life Sciences ,
Moderna Inc. ,
Pharmaceutical Industry ,
Scams ,
Spain ,
Vaccinations
Life Sciences and Health Care Horizons virtual event series -
The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more
11/17/2020
/ Artificial Intelligence ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Digital Health ,
Health Care Providers ,
Health Technology ,
Infectious Diseases ,
Innovation ,
Life Sciences ,
Pharmaceutical Industry ,
Physicians ,
Research and Development ,
Webinars
Since early this year, the COVID-19 virus substantially affects our daily life. Testing for the presence of or past exposure to the virus is an essential aspect of combatting the COVID-19 outbreak and a number of companies...more
10/22/2020
/ AFMPS ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
EU ,
EU Directive ,
Infectious Diseases ,
Medical Devices ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Agenda ,
Virus Testing
Our Medical Device and Technology team has been at the forefront of the COVID-19 legal response since the pandemic swept across the globe. In just a few short months, our team has taken on nearly 200 matters, ranging from...more
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time.
...more
4/21/2020
/ Collaboration ,
Coronavirus/COVID-19 ,
Defense Production Act ,
EU ,
Federal Trade Commission (FTC) ,
Fraud ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Public Health Emergency ,
Supply Chain
On 15 April 2020 the European Commission issued guidelines regarding COVID-19 in vitro diagnostic tests. The guidelines offer an overview of the different types of test and their purposes as well as the relevant EU regulatory...more
As a result of the COVID-19 outbreak and the associated quarantine and travel restrictions, the ability of notified bodies to conduct mandatory on-site audits under medical devices legislation has been significantly affected....more
The European Commission has submitted a proposal to the European Parliament and to the Council for a Regulation amending Regulation (EU) 745/2017 on medical devices. The purpose of the amendment is to defer application of the...more
The life sciences industry is facing unprecedented demands due to COVID-19. From front line carers to researchers and scientists, significant efforts are being put towards caring for those suffering from COVID-19 and...more