FDA Approves First Non-Chemotherapy Combination Regimen

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) approval of IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of Waldenström’s macroglobulinemia (WM), a rare blood cancer.1 The approval expands the label for IMBRUVICA in WM beyond its current approved use as a monotherapy to include … More FDA Approves First Non-Chemotherapy Combination Regimen

FDA Urged To Bring Stakeholders Together For Comprehensive And Permanent Solutions To Drug Shortage Crisis

The American College of Emergency Physicians (ACEP), the American Society of Anesthesiologists (ASA) and the American Academy of Ophthalmology (AAO) recently issued a statement regarding recent comments by Food & Drug Administration Commissioner Scott Gottlieb, M.D., on the current shortages of intravenous drugs and supply disruptions. ACEP President Paul Kivela, M.D., FACEP, says we are gratified by this statement as … More FDA Urged To Bring Stakeholders Together For Comprehensive And Permanent Solutions To Drug Shortage Crisis

FDA Seeks Permanent Injunctions Against Two Stem Cell Clinics

The U.S. Food and Drug Administration, in two complaints filed today in federal court, is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements. “Cell-based regenerative medicine holds significant medical opportunity, but we’ve also seen some bad … More FDA Seeks Permanent Injunctions Against Two Stem Cell Clinics

FDA Takes Unprecedented Step Toward Improved Inspections

The U.S. Food and Drug Administration has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight regulatory authorities found to be capable are those located in: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom. This achievement marks an important milestone to successful implementation and operationalization of … More FDA Takes Unprecedented Step Toward Improved Inspections