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相关临床试验
43
11 进行中
药物批准
133
批准总数
监管机构
3
监管机构数
成立时间
N/A
进行中（未招募）
6
13.9%
已完成
22
51.2%
尚未招募
5
11.6%
招募中
8
18.6%
暂停
2
4.7%
FDA
Food and Drug Administration
106
PHILIPPINES
Philippines FDA
NPRA
National Pharmaceutical Regulatory Agency
- India's first indigenous antibiotic nafithromycin faces regulatory scrutiny as the NPPA's expert committee questions whether the patent covers the approved formulation. - The Multidisciplinary Committee of Experts has directed verification from CDSCO and patent authorities to confirm alignment between the granted patent and approved drug formulation. - Wockhardt seeks five-year pricing exemption under DPCO 2013 for the groundbreaking antibiotic that targets drug-resistant Community-Acquired Bacterial Pneumonia. - The committee noted discrepancies between patent documents that don't explicitly mention "nafithromycin" and the specific CDSCO approval for 400mg tablets.
