摘要：
This past year was another successful year for the new drugs program in FDA’s Center for Drug Evaluation and Research (CDER).
CDER reviewed and approved 22 novel drugs, most of which have the potential to add significant clinical value to the care of thousands of patients with serious and life-threatening diseases.
Among the novel drugs approved in 2016 were the first treatment for patients with spinal muscular atrophy, the first drug approved to treat Duchenne muscular dystrophy, a new drug to treat hallucinations and delusions in people with Parkinson’s disease, another to treat patients with a rare chronic liver disease known as primary biliary cirrhosis, and two new treatments for patients with hepatitis C. There were also new oncology drugs to treat patients with ovarian cancer, bladder cancer, soft tissue sarcoma, and chronic lymphocytic leukemia — as well as two new diagnostic agents for detecting certain forms of cancer.
Supporting:
John Jenkins M.D.. A Review of CDER’s Novel Drug Approvals for 2016[J]. 中国药学(英文版), 2017, 26(2): 161-162.
John Jenkins M.D.. A Review of CDER’s Novel Drug Approvals for 2016[J]. Journal of Chinese Pharmaceutical Sciences, 2017, 26(2): 161-162.
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