FDA is making an example out of Abiomed, which Johnson & Johnson bought last year for $16.6 billion. In a warning letter that comes about a year after the agency issued guidance on its regulation of medical device data systems (MDDS), FDA reprimanded the company for not seeking approval of its software before putting it on the market.
privacy policy | terms of use | contact us | advertise | pharma jobs | pharma blogs | facebook | twitter
Copyright © 2024,