Concerned that the U.S. is becoming “overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations,” the House committee has launched its own investigation into the agency’s foreign drug inspection program.
Tag Archive for: House Committee on Energy and Commerce
The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen’s Alzheimer’s drug Aduhelm, which was “rife with irregularities,” a congressional report showed on Thursday.
