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Biden Administration supports waiver of WTO IP rights for COVID-19: Next steps for innovators

On 5 May 2021, U.S. Trade Representative Katherine Tai announced that the Biden Administration would support India and South Africa’s request for a World Trade Organization (WTO)...


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...


2020 OPDP Wrap-up: FDA monitoring drug manufacturers’ use of online communication platforms

In 2020, the U.S. Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued four warning letters and two untitled letters to pharmaceutical companies for...


FDA cracks down on pharmaceutical firm for misbranding drug as COVID-19 treatment

Last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted two more warning letters for 2020, bringing the tally to five warning and untitled ...


FDA proposes clarification in long-running tussle over “intended use” rules for drugs and devices

On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations to clarify the types of evidence FDA will consider when...


FDA Pre-Cert update: “more work needed” to refine Streamlined Review Framework

On September 14, the U.S. Food and Drug Administration (FDA) announced that it released an eight-page update on the status of the Digital Health Software Precertification (Pre-Cert) Pilot...


At long last, landmark OTC Drug reform legislation is enacted

On March 27, 2020, as part of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), U.S. President Trump signed into law a long-awaited overhaul of the regulatory system for...


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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