FDA Approvals - FDA Seizes Contaminated Heparin From A Cincinnati Manufacturer (Medical News
FDA Seizes Contaminated Heparin From A Cincinnati Manufacturer (Medical News Today)
As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government today seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio. The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals.
US FDA suspends drug approvals from Sun's US subsidiary Caraco (Business Standard India)
The United States Food and Drug Administration (USFDA) has on October 31 issued a warning letter to Caraco Pharmaceutical Laboratories, the US subsidiary of Sun Pharmaceuticals Ltd, withholding all future marketing approvals for medicines manufactured from Caraco s production facility in Detroit.
Biotech Mailbag: Who Will Run FDA? (TheStreet.com)
The FDA is in turmoil. Morale is low, resources are scarce and too many drug approvals have been delayed at best, or at worst, have become politicized. A look at some options to run the agency in the Obama administration.