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.”
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.”
People
Related News
03 May 2024
In the News
Jeff Symons’ Move to Foley Featured in Press
Foley & Lardner LLP partner Jeff Symons is featured in legal press for his recent arrival to the firm
03 May 2024
In the News
Nathaniel Lacktman on Healthleaders Podcast– ‘We’re seeing maturity in the telemedicine market’
Foley & Lardner LLP partner Nathaniel Lacktman discussed the upcoming American Telemedicine Association’s annual conference, new developments in telemedicine and digital health, the regulatory context, and the prospects for the industry’s future
02 May 2024
In the News
Jennifer Hennessy on American Privacy Rights Act – ‘This law does have teeth’
Foley & Lardner LLP partner Jennifer Hennessy assesses the prospects of what could be the first federal data privacy law passed in the United States