The changes clear the way for Cuban-origin pharmaceuticals to gain U.S. regulatory approval. And instead of special quotas, normal limits on Americans' importation of foreign products will apply.
Orphan drug regulations are intended ease the regulatory process and lower barriers for medicines that address rare medical conditions. Otherwise, the costs of research, winning regulatory approval, and production could well exceed ...
U.S. citizens traveling abroad can bring home all the Cuban rum and cigars they want.