Publications

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The impact of COVID-19 on clinical trials and countermeasure development in Japan

On 19 March 2020, the Ministry of Health, Labour and Welfare of Japan (MHLW) issued a notice announcing a waiver of the statutorily-required waiting period after submitting a request for...

Hogan Lovells Publications

Podcast: Talking the cure

Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients. Over the next year, we will touch on cutting edge topics such as...

News

Expanded access to telehealth services during the COVID-19 pandemic

In response to the COVID-19 pandemic, the U.S. Congress, the Centers for Medicare and Medicaid Services (CMS), many state legislatures and state Medicaid programs, and private payers have...

News

The AFMPS issues decision regarding urgent measures to fight shortage of medicines due to COVID-19

The General Administrator of the AFMPS issued a Decision on 1 April 2020 introducing urgent measures regarding specific medicinal products used in the context of the SARS-CoV-2 pandemic....

News

FDA creates Coronavirus Treatment Acceleration Program to speed COVID-19 therapy development

The U.S. Food and Drug Administration (FDA) on March 31 announced the establishment of a special emergency program to help speed actions on possible COVID-19 therapies. The Coronavirus...

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Additional German guidance on the management of clinical trials during the COVID-19 pandemic

Further to the European Guidance on the Management of Clinical Trials during the COVID-19 pandemic, the German higher federal authorities (the Federal Institute for Medicinal Products and...

News

First emergency use authorization for COVID-19 drugs may open door for more EUAs

The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) allowing distribution of two decades-old malaria drugs — Chloroquine Phosphate and...

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Italian Law Decree no. 18/2020: impacts on the life sciences industry

Recent developments in Italy in response to the COVID-19 public health crisis: The Cura Italia Decree provides for public funds to support increased production of medical devices and...

News

Stark Law waivers, HHS-OIG announcement offer health care providers greater flexibility during COVID-19 pandemic

On Monday, March 30, the Centers for Medicare & Medicaid Services (CMS) announced an array of temporary regulatory waivers and new rules to equip the American health care system with...

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