Clinical Research Solutions
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...
Clinical Research Solutions
ANDA Development Made Clear: Expert Advice on Submission Strategy, Labeling, and Patent Considerations
Inside our Q&A session with former FDA labeling reviewer, Marshall Florence, PharmD., regarding ANDA submission strategy, labeling, and how to effectively use the OrangeBook as a strategic resource....
Clinical Research Solutions
Leveraging Online FDA Information to Accelerate ANDA Timelines
In the race to generic drug approval, timing is everything. Delays in Abbreviated New Drug Application (ANDA) submissions or setbacks during FDA review can mean missed market opportunities,...