如何在 FDA 的监管下开发孤儿药
罕见病是公共卫生领域的优先事项。FDA has launched several programs and a final guidance to address the unmet need for orphan drugs.
Tag: FDA
FDA Draft Guidance on Planned PMR/PMC Forms 3988 & 3989
What you need to know about the FDA’s proposed new PMR/PMC forms In October 2020, FDA released a draft guidance indicating that they will be encouraging the use of new forms FDA 3988 and FDA 3989 to improve the agency’s collection, identification, and use of information regarding PMRs (post marketing requirements) and PMCs (post marketing commitments). The … Continued
Certara 宣布美国食品药品监督管理局对 Certara 生物模拟软件用于审查监管申报材料的事项予以更新与扩充
FDA holds more than 400 SimcypTM and PhoenixTM software licenses across 12 divisions and offices PRINCETON, N.J.— 2021 年 12 月 21 日 – Certara, Inc. （纳斯达克股票代码：CERT), a global leader in biosimulation, today announced that the U.S. Food and Drug Administration (FDA) has renewed and expanded its licenses of Certara’s proprietary biosimulation software, with more than 400 … Continued
COVID-19 Vaccines Update: US Approval Vs Authorization as of 2021 年 12 月 3 日
My previous blog on COVID-19 vaccines as of 2021 年 10 月 11 日 clarified and discussed the differences in terms and definitions for Emergency Use Authorization (EUA) and “full” FDA approval and presented a table of EUA and approved COVID-19 vaccines in the United States. Since October 11, there have been numerous additions to the EUAs including … Continued
滚动提交 NDA 和 BLA：加快审阅时间表
Accelerate your FDA review process with a rolling NDA/BLA eCTD submission with Certara’s GlobalSubmit eCTD software and eCTD publishing specialists
New FDA Guidance on Penalties Relating to ClinicalTrials.gov
By Carrie Mitchell and Jason Buck Recently, the FDA issued a guidance concerning the penalties for noncompliance with ClinicalTrials.gov requirements. Sponsors conducting clinical trials should understand and follow the requirements for registering trials and reporting the results on ClinicalTrials.gov. The requirements have been in force since 2007 and were part of Section 801 of the … Continued
Modeling and Simulation: Optimizing Phase 3 Study Design to obtain FDA Approval
Modeling and simulation were used to optimize a sponsor’s Phase 3 clinical trial study design to achieve efficacy and safety goals as well as regulatory approval.
Phoenix NLME 和 Trial Simulator 使口服睾酮替代品获得 FDA 批准
Clarus Therapeutics received FDA approval for an oral testosterone (T) replacement drug. This webinar will review how Phoenix NLME, population PK/PD M&S tool, and Trial Simulator supported this approval.
Certara Supported 90+ Percent of US FDA Novel New Drug Approvals for Sixth Consecutive Year
PRINCETON, NJ – Jan. 23, 2020 – Certara today reported that more than 90% of novel new drug approvals by the US Food and Drug Administration (FDA) in 2019 were supported by Certara software or services.
New FDA Initiatives: Project Orbis and Real-Time Oncology Review
The U.S. Food and Drug Administration (FDA) recently announced two exciting and innovative initiatives from FDA’s Oncology Center of Excellence: Project Orbis and Real-Time Oncology Review (RTOR) Pilot Program. Project Orbis Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), will provide a framework for concurrent submission and review of oncology products between international … Continued
