News & Resources
Archive by Year: 2011 - Page 2
Litigation is mounting against General Electric Co. over Omniscan, an allegedly toxic injectable contrast agent used in MRI. Omniscan, or gadodiamide, is widely popular injectable used in patients about to undergo MRIs or arteriorgraphy in order to make it easier for physicians to see lesions with abnormal blood flow.
The FDA has revealed a new program designed to speed up the approval process of generic drugs. The new drug review program called Generic Initiative for Value and Efficacy (GIVE) aims to significantly increase the number of generic drugs approved each year.
The FDA has created a new 15-member advisory panel to advise the agency about the best methods to educate consumers about the risks and benefits about the products it regulates.
Millions of patients enroll in clinical trials every year for experimental drugs and medical devices, but a federal investigation conducted by Inspector General Daniel R. Levinson of the Department of Health and Human Services has revealed that patients are rarely watched over or receive little or no FDA protection.
The FDA oversees the regulation of medical devices and more than $1 trillion annually worth of food, drugs, dog food, cosmetics, and other products.