Author name: admin22

U.S. Food and Drug Administration issued two final guidances, “Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices” and “Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.”

The U.S. Food and Drug Administration (FDA) has approved Cardamyst (etripamil) nasal spray to treat episodes of paroxysmal supraventricular tachycardia (PSVT), a condition where the heart beats abnormally fast.