Published in FDA Law Weekly, April 15th, 2004
On February 2, 2004, the FDA accepted for priority review the company's New Drug Application (NDA 21-661) seeking approval to market RSR13 as an adjunct to whole brain radiation therapy for the treatment of patients with brain metastases originating from breast cancer. The FDA has established a target date of June 4, 2004, to take action on the NDA.
"We welcome the additional review and insight the FDA's...
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