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Regulatory Requirements Biologics Coronavirus/COVID-19

McDermott+

Trump Administration Executive Order Tracker

McDermott+ on

Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

McDermott Will & Emery

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Hogan Lovells

FDA advises drug manufacturers on best practices for restarting operations during COVID-19 pandemic

Hogan Lovells on

On September 11, the U.S. Food and Drug Administration (FDA) issued a temporary guidance, “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency,” urging drug manufacturers to...more

Hogan Lovells

FDA extends enforcement discretion period for regenerative medicines, citing COVID-19 challenges

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) extended the enforcement discretion period for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps) by an additional six months, citing the challenges...more

Morgan Lewis

FDA COVID-19 Guidance Roundup for Drug and Biologics

Morgan Lewis on

From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more

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