On July 25, 2014, the United States Food and Drug Administration issued new guidance regarding its 510(k) process, which is one of the processes by which manufacturers may obtain FDA approval for new medical devices. The 510(k) process allows manufacturers to seek approval to market a new medical device based on the proposition that the new device is “substantially equivalent” to a previously approved and marketed device. As part of this process, manufacturers are able to put forth less clinical evidence in regard to the new device, and to primarily rely on data regarding the previously approved device (or predicate device).
Drug Litigation Blog Posts:
The Alabama drug injury lawyers at Cory Watson Attorneys explain that doctors have a responsibility to ensure patients receive the correct and appropriate dosages of medication needed to treat a
There is growing concern over serious side effects related to the following prescription medications: Benicar®, Benicar HCT®, Tribenzor®, and Azor®. These medications are prescribed for the
On December 18, 2014, a motion was filed with the United States Judicial Panel on MultiDistrict Litigation (JPML) seeking consolidation and transfer of pending federal cases involving the
What do consumers need to know about the history of Zofran use in the U.S.? Here are some key dates: Zofran has been on the market since January 1991, when the U.S. Food and Drug Administration