German drug maker Bayer AG "mistakenly" failed to inform U.S. regulators about a study on the risks of heart-surgery drug Trasylol before an advisory panel met and ruled the side effects were acceptable, the company said on Friday.
Bayer believes that despite the highly preliminary nature of this data, the information should have been shared with the FDA prior to the September 21 advisory committee meeting ... This was a mistake on the company's part
Continue reading Bayer says mistakenly failed to disclose drug data.
