LEXOLOGY

FDA publishes draft guidance describing pathways for combination product review The guidance outlines the principles for premarket review of...

On February 10, 2022, the U.S. Food and Drug Administration (FDA) held a public Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the...

Following our article “Brexit with or without a deal: Consequences for pharmaceutical companies”, which provided a general overview of the...

The MHRA has issued updated guidance on its plans for the regulation of medicines, medical devices and clinical trials in the event that the...

The Chinese government has issued draft amendments to the Drug Administration Law and a draft Vaccine Administration Law for public comment....

Use the Lexology Navigator tool to compare the answers in this article with those from other jurisdictions. Trends and developments Legal...

It has been just about two years since the Central District of California dismissed the claims in Nexus Pharmaceuticals, Inc. v. Central...