Tag: Hatch-Waxman Act
180-Day Exclusivity and Authorized Generics: Legal Considerations in the U.S. Drug Market
The 180-day exclusivity rule for generic drugs was designed to reward patent challengers-but brand companies can legally launch their own versions during that time, slashing profits and undermining competition. Here’s how it works and why it’s broken.
FDA Office of Generic Drugs: Role, Responsibilities, and Structure Explained
The FDA Office of Generic Drugs ensures safe, affordable generic medications reach patients by reviewing applications, enforcing quality standards, and managing regulatory frameworks like GDUFA and Hatch-Waxman.