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FDA explains when medical device makers must notify of an interruption in manufacturing

On Monday, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under...

News

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 transition plan for COVID-19 medical devices requests new submissions to agency

On December 22, 2021, the U.S. Food and Drug Administration (FDA) published two draft guidance documents intended to help medical device manufacturers transition out of the temporary rules...

Hogan Lovells Podcasts

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 (December 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

HHS again permits FDA review of LDTs, updates EUA policy for laboratory developed tests

On November 15, the U.S. Department of Health and Human Services (HHS) withdrew a controversial Trump-era HHS Policy Change that effectively prevented the Food and Drug Administration (FDA) ...

News

COVID-19 Report for Life Sciences and Health Care Companies (November 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 (October 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 (September 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.

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