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The FDA acknowledged the need for greater transparency and an increased focus on safety in its drug review process through a series of recommendations it issued late yesterday.
Amgen’s anemia drug Aranesp should not be used to treat fatigue or to reduce the need for red blood cell transfusions in cancer patients because it is ineffective and potentially dangerous for these uses, the company said.
The FDA wants to impose new electronic reporting requirements on biological product manufacturers to assist in potential product recalls, the agency said.
The FDA warned Daiichi Sankyo for promotional items it said were misleading because they obscured risk information for Evoxac, a drug that treats dry mouth in patients with Sjogren’s syndrome.
FDA investigators found that Apple Medical’s procedures regarding its gynecologic electrocautery devices violated several current good manufacturing practice regulations, the agency said in a warning letter.
HemoSense's medical devices are adulterated due to current good manufacturing practice violations regarding its complaint handling and investigating system, an FDA warning letter said.
The FDA learned through Hardy Diagnostics’ recent voluntary recall of its HardyCHROM O157 device that the company was marketing the device without approval, an agency warning letter said.
Swedish firm Straumann recently reported that its oral regenerative product company, Biora AB, had received an FDA warning letter informing the firm that its dental bone grafting materials have been placed under a U.S. import alert.
In one of the first oversight actions of the new Congress, members of the House Committee on Energy and Commerce released a letter sent to FDA Commissioner Andrew von Eschenbach announcing an inquiry into one of the agency’s contracts.