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FDA expands mutual reliance and harmonization with foreign regulators for inspectional oversight

The U.S. Food and Drug Administration’s (FDA) commitment to expand mutual reliance with trusted regulatory partners may be a silver lining for biomedical innovation during an...

News

FDA issues guidance on conducting remote interactive evaluations during the COVID-19 pandemic

On April 14, the U.S. Food and Drug Administration (FDA) released the immediately-in-effect guidance “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring...

News

Safeguarding drug development at academic institutions

Academic institutions and faculty engaged in developing novel drug therapies are navigating an increasingly complex compliance landscape. Innovative therapies are moving from university...

Hogan Lovells Publications

Life sciences and health care horizons 2021

Companies in the life sciences and health care industry navigated unparalleled challenges in 2020. The pandemic forced the development and adoption of new technologies and innovations...

News

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

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...

News

FDA updates industry on what drug & biologic inspections will occur during COVID-19 pandemic

On Wednesday, August 19, the U.S. Food and Drug Administration (FDA) issued guidance providing some additional insight into how the agency will determine what drug and biologic inspections...

News

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

Today, 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...

News

FDA to restart domestic inspection program using new Advisory Rating system

The U.S. Food and Drug Administration (FDA) said Friday it plans to resume on-site inspections of FDA-regulated facilities and other associated activities the week of July 20, 2020. The...

News

New FDA inspection program released for “streamlined approach” for combination product cGMP

On June 4, 2020, the U.S. Food and Drug Administration (FDA) updated the Compliance Program Guidance Manual (CPGM) to include a program for “Inspections of CDER-led or CDRH-led...

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