Health Canada recently published draft regulations to address therapeutic product shortages in Canada. The Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of...more
Medical device, drug, food, cosmetic, and other FDA-regulated product manufacturers face the constant threat of product liability lawsuits. Claims of injuries from allegedly defective products can lead to significant...more
Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department of Health and Human Services (HHS), media reports have featured opinions from...more
The Food and Drug Administration (FDA) has announced implementation of a new “concept of operations” that seeks to improve FDA’s oversight over pharmaceutical manufacturers. The concept of operations complements FDA’s program...more
In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement...more
On Tuesday, President Obama signed the 21st Century Cures Act (the “Act”) into law. The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product...more
Summer is in full swing and certain topics are (staying) hot—especially regulatory issues, from new proposed rules to challenges to case law to strategic considerations. Generic preemption remains a hot topic. In Storm...more