Regulatory Sciences
Skinny Labels Under the Microscope: What Hikma v. Amarin Means for Drug Developers
In today's evolving regulatory and legal landscape, few issues are as consequential for generic drug development as the use of so-called "skinny labels." The recent decision by the U.S. Supreme Court...
Regulatory Sciences
Navigating FDA Layoffs: How Policy Layoffs May Impact Generic Drug Development
Layoffs at the Office of Generic Drug Policy Could Slow Development—but Strategic Guidance Can Help Sponsors Stay on Track The FDA has recently undergone a wave of layoffs that are beginning to...
Regulatory Sciences
FDA Publishes Complex Generics News Resource
Today the FDA is publishing a new web page to share the most recent FDA actions and activities related to complex generics. This new resource is part of FDA’s continued commitment to ensuring...