FDA Approvals - Drugmakers' payments to FDA for reviews to increase by 29%
Drugmakers' payments to FDA for reviews to increase by 29% (Chicago Tribune)
Drugmakers have agreed to a nearly 29 percent increase in payments to federal regulators to ensure speedy approvals of new medicines and step up safety monitoring, a person familiar with the deal said Tuesday.
FDA Approves First Generic Ondansetron Injection (U. S. Food and Drug Administration)
Ondansetron is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy (cancer therapy that causes vomiting) and prevention of postoperative nausea and vomiting.
Repligen Receives Orphan Drug Designation From the FDA for RG1068 for MRI Imaging of the Pancreas (RedNova)
WALTHAM, Mass., Nov. 21 /PRNewswire-FirstCall/ -- Repligen Corporation announced today that the Office of Orphan Products Development of the U.S.