| 查看: 291 | 回复: 0 | |||
1949stone荣誉版主 (知名作家)
海纳百川
|
[交流]
FDA-CDER’s Quality Initiative
|
CDER’s Quality Initiative http://www.fda.gov/AboutFDA/Cent ... /CDER/ucm417014.htm Quality is the underpinning of everything FDA does to help assure consumers have access to quality medicines, regardless of whether the medications are over-the-counter, prescription, innovator, or generic. Without quality, no one can be confident that a drug is safe and effective. To meet the needs of the global pharmaceutical market, we are working to enhance our robust drug quality program, similar to what the center has in place for drug safety and efficacy. CDER’s Quality Initiative began more than a decade ago when the agency first introduced the 21st Century Initiative to modernize FDA’s regulation of the pharmaceutical quality of drugs. The initiative included issues related to product quality, with current good manufacturing practices as important tools for improving overall product quality. The Food and Drug Administration Safety and Innovation Act of 2012 further enhanced CDER’s Quality Initiative by directing FDA to, among other things, improve its risk-based surveillance inspection schedule of manufacturing facilities. To implement this approach, FDA will use performance measures to assess a facility’s quality system to assure product quality. This practice will sharpen FDA’s focus on issues that are critical to quality and create a common language to gauge progress around quality. It will also allow FDA to identify and respond to quality issues at manufacturing facilities before those issues become major, systemic problems. The Office of Pharmaceutical Quality (OPQ) further enhances CDER’s Quality Initiative by creating a drug quality program as robust as the programs the agency already has in place for drug safety and efficacy. OPQ will streamline FDA processes that monitor drug quality throughout the product lifecycle, including drug application review, post-approval improvements, and surveillance and inspections of global manufacturing facilities. |
回复此楼» 猜你喜欢
【2026 硕士调剂】 全国重点实验室 药学 化学 生物学 生物与医药
已经有0人回复
-
药学 化学 生物学 生物与医药 河南师范大学抗病毒性传染病创新药物全国重点实验室
已经有0人回复
-
药物学论文润色/翻译怎么收费?
已经有151人回复
-
江西
已经有13人回复
-
江西科技师范大学086生物与医药
已经有15人回复
-
BL21(DE3)UV或者丝裂霉素诱导条件下会释放DE3的噬菌体吗？
已经有14人回复
-
🔥速览｜AACR 2026 mRNA肿瘤疫苗临床捷报
已经有0人回复
-
深圳理工大学和东南大学联合培养博士招生（2026年9月入学）
已经有11人回复
-
211高校2026年入学博士名额
已经有14人回复
-
211高校2026年入学博士名额
已经有15人回复
-
211高校2026年入学博士名额
已经有15人回复
点击这里搜索更多相关资源