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COVID-19 Report for Life Sciences and Health Care Companies

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time....

News

FDA warns over use of robotically-assisted surgical devices

Last week, the U.S. Food and Drug Administration (FDA) issued a safety communication to remind patients and health care providers that the safety and effectiveness of...

News

FDA seeks comments on how to transition approved drug products to device status under Genus

On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision&n...

News

After a long and winding road, FDA finalizes much-debated “intended use” rule

On August 2, 2021, the U.S. Food and Drug Administration (FDA) published a final rule to amend its “intended use” regulations, codified at 21 CFR § 801.4 for medical...

News

COVID-19 Report for Life Sciences and Health Care Companies (August 2021)

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time....

News

COVID-19 Report for Life Sciences and Health Care Companies (July 2021)

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.

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

COVID-19 Report for Life Sciences and Health Care Companies (June 2021)

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.

News

Federal court limits FDA discretion in “drug” vs. “device” classification

The U.S. Court of Appeals for the D.C. Circuit recently decided in Genus Medical Technologies LLC v. U.S. Food and Drug Administration that, when classifying a biomedical product as either...

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