Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new drug applications or supplements listing your firm as a drug manufacturer. 在你们完全纠正所有违法行为并且我们确认你们遵守CGMP之前,对于将你们公司列为生产商的新药申请或补充申请,FDA...
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Generally, approved products are added to the Discontinued Section of the Orange Book when the applicant holder notifies the Orange Book staff of the products』 not marketed status. Products may also be added if annual reports indicate...
Your firm used recovered solvents such as(b)(4)and(b)(4)from multiple external contract manufacturers, including(b)(4). In January 2019 you restricted the procurement of all(b)(4)-related materials from(b)(4)and in March2019, you removed...
2月9日,FDA公布一封针对美国本土企业(Allay Pharmaceuticals)的警告信,主要的缺陷项涉及工艺验证、OOS调查、稳定性数据等问题。 FDA表示,对于某个验证批,时隔一年之后,该公司才启动长期稳定性研究(2020年5月1日),而这一决定刚好发生在FDA检查(2020年5月5日)开始前的几天。另外,对于某API,该公司的含量检验结果与...
2月9日,FDA公布一封针对美国本土企业(Allay Pharmaceuticals)的警告信,主要的缺陷项涉及工艺验证、OOS调查、稳定性数据等问题。 FDA表示,对于某个验证批,时隔一年之后,该公司才启动长期稳定性研究(2020年5月1日),而这一决定刚好发生在FDA检查(2020年5月5日)开始前的几天。另外,对于某API,该公司的含量检验结果与...
The FDA (Food and Drug Administration) does not conduct pre-market authorization of dietary supplements. And no dietary supplements in the United States are “FDA approved.” The Food and Drug Administration regulates dietary supplements under the Dietary Supplement Health and Education Act (DSHEA)....
The guidance also recommends that the applicant include a summary of all changes that were made to the device during the reporting period, including listing all supplements submitted during the reporting period and, if approved, their approval date. Having the information submitted in this way will...
2. Analysts manually reprocessed chromatograms by adding integration events that were not approved by QC management.2. 分析人员通过添加未经QC管理层批准的积分事件来手动重新处理色谱图。此外,您缺乏描述分析人员何时可以手动输入积分事件、应如何使用这些事件或应如何查看这些事件的适当过程。(西门君:手动积分必须...
new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C...