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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.

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Publications

Hogan Lovells Publications

Virtual health horizons 2020

As the world responds to the COVID-19 pandemic, physicians and patients are increasingly turning to virtual health solutions, including telehealth and remote monitoring, as a central facet...

News

FDA creates Coronavirus Treatment Acceleration Program to speed COVID-19 therapy development

The U.S. Food and Drug Administration (FDA) on March 31 announced the establishment of a special emergency program to help speed actions on possible COVID-19 therapies. The Coronavirus...

News

The global impact of COVID-19 on clinical trials and countermeasure development
Registered Content

The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of...

Insights

“Misleading” to suggest a biosimilar is inferior, FDA draft guidance warns
Registered Content

As part of its continuing efforts to advance biologics competition, the U.S. Food and Drug Administration (FDA) on February 3 published a 10-page Q&A draft guidance, “Promotional...

Insights

2019 OPDP enforcement letters target how drug risk information is conveyed in promotional materials
Registered Content

In 2019, the U.S. Food and Drug Administration's ("FDA" or "the Agency") Office of Prescription Drug Promotion (OPDP) issued three warning and seven untitled letters ...

News

FDA may accept DMFs for electronics and software components of drug-led combination products

On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could...

Insights

ICMJE requires registrations for clinical trials to include disclosure of data sharing plan
Registered Content

Clinical trials starting patient enrollment this year must include a "data sharing plan" in their trial registrations (such as on ClinicalTrials.gov), according to a policy...

Media Mention

8 Promo Pitfalls Pharma Compliance Chiefs Need to Know Law360

Susan Lee was quoted in the Law360 article titled "8 Promo Pitfalls Pharma Compliance Chiefs Need to Know."

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