Partner David Rosen was quoted in a Korea Biomedical Review
article, "How Korean pharma companies can succeed in US
," about how Korean pharmaceutical and biosimilar companies can find success in America.
Rosen, speaking at BIO KOREA 2019, said it is essential for Korean companies to develop drugs with a sense of responsibility for making the products safe. He also said if such expectations are not met, the companies can receive sanctions and penalties, including regulatory enforcement action, civil monetary penalties, and criminal liability.
"Import detention is something that everyone should be afraid the most as the Food and Drug Administration can block any import of the product," he said. "Therefore, companies have to respond to all warning letters and the concerns that the FDA has, and address them."