Questions and Answers on Zegerid OTC The Food and Drug Administration (FDA) has approved Zegerid OTC, an over-the-counter treatment for frequent heartburn. 1. What is Zegerid OTC and what is it used to treat? Zegerid OTC contains the proton pump inhibitor, omeprazole, and is used to treat...
(FDA)多个中心或办公室联合发布了题为《良好实验室规范(GLP)研究报告翻译:问题与解答行业指南(草案)》(Translation of Good Laboratory Practice Study Reports: Questions and Answers Guidance for Industry(DRAFT GUIDANCE) )的指南就如何翻译符合GLP要求的研究报告提供指导性意见,以确保GLP研究报告翻译的规范性、清晰...
9月20日,FDA发布Questions and Answers on Quality Related Controlled Correspondence Guidance for Industry,其中有问题:如果 FDA溶出方法数据库或美国药典 (USP) 中没有拟定仿制药的溶出方法,FDA能否提供该产品的溶出方法?看看FDA怎么规定的吧! 问题: 如果FDA溶出方法数据库或美国药典 (USP) 中没有拟定仿制药的溶出...
fda had previously issued guidance9 regarding the use of voluntary remote interactive evaluations of certain establishments during the covid-19 public health emergency; a remote interactive evaluation is a type of rra. the agenc...
9月20日,FDA发布Questions and Answers on Quality Related Controlled Correspondence Guidance for Industry,其中有问题:如果 FDA溶出方法数据库或美国药典 (USP) 中没有拟定仿制药的溶出方法,FDA能否提供该产品的溶出方法?看看FDA怎么规定的吧! 问题: 如果FDA溶出方法数据库或美国药典(USP) 中没有拟定仿制药的溶出...
FDA Publishes Frequently Asked Questions and Answers for Proposed FSMA RulesMelvin S. DrozenKathryn C. Skaggs
ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (May 2021) Q8, Q9, & Q10 Questions and Answers — Appendix: Q&As from Training Sessions (July 2012) Process Validation: General Principles and Practices (January 2011) ...
c. 如果收到又一客户投诉问题正是仍处于调查阶段的同一FAR问题,是否应该提交后续FAR呢? d. 应何时提交最终FAR? 现将全文翻译如下,期望为各药企提供些许参考价值。 点击可放大查看 🔻 I. INTRODUCTION介绍 II. BACKGROUND 背景 III. QUESTIONS AND ANSWERS 问与答...
II. Questions and Answers 1. What is a medical food? A medical food, as defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is ...
Questions and Answers on Current Good Manufacturing Practices—Equipment FDA cGMP问答—设备13问 1. Many leading analytical balance manufacturers provide built-in "auto calibration" features intheir balances. Are such auto-calibration procedures acceptable instea...