Podcast: Non-binding Guidance: Breakthrough Devices Program
Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and...more
The California Environmental Quality Act (CEQA) has long shaped the state’s development landscape, often entangling projects in lengthy permitting and litigation processes. That landscape has now shifted dramatically. ...more
We are living in an era of revolutionary medical innovation, particularly in the research and development of medicinal products. Diseases that were once considered incurable, are now treated with drugs, vaccines and...more
Included in the CARES Act are long-awaited reforms to the FDA’s regulation of over-the-counter (OTC) medications. H.R. 748, §§ 3851-3862. The FDA has hailed the law as granting it “transformative, new authorities that will...more
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 Over-the-Counter (OTC) drugs. ...more