Agnes Shanley, Editor || March 20, 2014 At the PDA conference track at Interphex 2014 in New York City, Richard Friedman, Associate Director of FDA’s
Office of Manufacturing & Product Quality, discussed what differentiates reliable from unreliable aseptic processes.
June 2, 2010 Amgen received approval from the FDA for Prolia (denosumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
April 14, 2010 Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) received approval from the FDA for its NDA for Pancreaze (pancrelipase) delayed-release capsules for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or ot
March 31, 2009 WuXi AppTec's Bioanalytical Services (BAS) unit was successfully inspected by the FDA without the issuance of a Form 483.WuXi AppTec's Bioanalytical Services (BAS) unit was successfully inspected by the FDA without the issuance of a Form 483.