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2024 Life Sciences & Health Care Horizons

While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent ...

News

The False Claims Act Guide: 2023 and the road ahead

In the latest edition of our False Claims Act Guide: 2023 and the road ahead, we analyze the key developments from 2023 and discuss how the most important cases and issues are shaping FCA...

Insights and Analysis

Life Science Law Update – Key developments for pharma & device companies in EU and EU Big Five

In this Q4/23 issue of our Life Science and Health Care Law Update, our teams highlight key trends across life sciences regulatory, corporate, compliance, competition, and privacy...

News

Florida still has a long way to go before it can begin importing certain Canadian drugs

On January 5, 2024, the U.S. Food and Drug Administration (FDA) authorized Florida’s proposal under the Section 804 Importation Program (SIP) to allow Florida to proceed to the next...

News

FDA warns animal drug companies over unapproved antimicrobials, identifying “public health concerns”

In December 2023, the U.S. Food and Drug Administration (FDA) issued nine Warning Letters for the manufacture and distribution of unapproved over-the-counter (OTC) antimicrobial animal...

News

U.S. FDA: labeling guidance for sponsors incorporating prescription drug use-related software

The U.S. Food and Drug Administration (FDA) published new draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software” (PDS Guidance), which...

News

The “Borne Mission” Report analysis: Between hope and disappointment for the pharmaceutical industries

Borne's long-awaited Report on regulation of healthcare products has fallen well short of pharmaceutical industry expectations. Indeed, it contains very few concrete proposals.

News

Regulation of drug and medical device advertising in China: an industry under the microscope

In recent years, there has been an uptick in interest in the Chinese market from licensors based predominantly in the U.S., Canada, Europe, and South Korea. Factors encouraging the...

Insights and Analysis

Life Science Law Update – Key developments for pharma & device companies in EU and EU Big Five

In this third issue of our Life Science and Health Care Law Update, our teams highlight key trends across life sciences regulatory, corporate, compliance, competition, and privacy...

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